U.S. patent number 5,335,373 [Application Number 07/800,487] was granted by the patent office on 1994-08-09 for protective medical gloves and methods for their use.
Invention is credited to Kenneth H. Dangman, Karl P. Dresdner, Jr., Edward A. Jazlowiecki.
United States Patent |
5,335,373 |
Dresdner, Jr. , et
al. |
August 9, 1994 |
**Please see images for:
( Certificate of Correction ) ** |
Protective medical gloves and methods for their use
Abstract
A protective medical glove containing a liquid antiseptic
composition and methods for its use are disclosed. The flexible
glove comprises at least a thin inner layer and at least a thin
outer layer of material; the outer layer is preferably the more
elastic and less plastic layer. Between the layers of the glove, a
liquid antiseptic composition is stored which comprises an
antiseptic in a liquid. The liquid antiseptic composition may also
contain a surface-active agent, an algesic agent, a colorant, a
vasoconstrictive agent, a smell-causing chemical, and a
viscosity-modifying agent. A glove puncture by an object may cause
some transfer of liquid antiseptic composition from the glove onto
the hand and into a hand wound should the wound occur; useful as an
immediate treatment to help to prevent a possible systemic
infection by a pathogen in the individual; the treatment can help
to protect a gloved individual such as a surgeon, a medical doctor,
a health care worker or another worker whose work may place them at
risk of becoming contaminated by a glove-puncturing object
contaminated with the AIDS virus, hepatitus B virus or another
infectious pathogen.
Inventors: |
Dresdner, Jr.; Karl P. (New
York City, NY), Dangman; Kenneth H. (New York City, NY),
Jazlowiecki; Edward A. (Forestville, CT) |
Family
ID: |
25178525 |
Appl.
No.: |
07/800,487 |
Filed: |
November 29, 1991 |
Current U.S.
Class: |
2/161.7; 2/167;
604/292; 2/168 |
Current CPC
Class: |
A61B
42/10 (20160201); A41D 19/0058 (20130101); A41D
19/0096 (20130101); A61B 42/00 (20160201); A61L
31/16 (20130101); A61L 2300/404 (20130101); A61L
2300/608 (20130101) |
Current International
Class: |
A41D
19/00 (20060101); A61B 19/04 (20060101); A61B
19/00 (20060101); A61L 31/14 (20060101); A61L
31/16 (20060101); A41D 019/00 () |
Field of
Search: |
;2/167,168,169,164,161R,159,161.7,901 ;128/292,306,307
;604/292 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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WO 91/10409 |
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Jul 1991 |
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WO |
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9014048 |
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Nov 1990 |
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WO |
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Other References
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745. .
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Normal Wound Healing", 1980, Arch. Surg., 115, pp. 253-256. .
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Iodine-Containing Solutions in Wounds", 1982, Arch. Surg., 117, pp.
181.varies.186. .
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Nosocomial Infections"(Guideline for hospital environmental
control), Am. Journal of Infection Control, 1983, 11[3], pp.
91-120. .
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Nosocomial Infections" (Guideline for prevention of surgical wound
infections), Am. Journal of Infection Control, 1983, 11[4], pp.
133-143. .
Hicks, et al., "Inactivation of HTLV-III/Lav-Infected Cultures or
Normal Human Lymphocytes By Nonoxynol-9 in Vitro", 1985, Dec.
21/28, The Lancet, pp. 1422-1423. .
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Ectoparasiticides", 1985, In: The Pharmacological Basis of
Therapeutics; 7th ed., Chapter 41, pp. 959-979. .
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1985; The Journal of the Am. Med. Assoc., vol. 254, No. 15; pp.
2089-2093. .
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Against Human Immunodeficiency Virus," 1988, The Journal of the Am.
Med. Assoc., 259[12], pp. 1851-1853. .
Newsom, et al., "What is in the Surgeon's Glove?", 1988, Journal of
Hospital Infection, 11[supplement A], pp. 244-259. .
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Surgeons", 1988, Am. College of Surgeons Bulletin, 73[3], pp. 4-10.
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Gerberding, et al., "Risk of Exposure of Surgical Personnel to
Patients' Blood During Surgery at San Francisco General Hospital",
The New England Journal of Medicine. 1990. 322[25] pp. 1788-1793.
.
Monteflori, et al., "Effective Inactivation of Human
Immunodeficiency Virus With Chlorhexidine Antiseptics Containing
Detergents and Alcohol", 1990, Journal of Hospital Infection, 15,
pp. 279-282. .
Speller, et al., "Acquired Immune Deficiency Syndrome:
Recommendations of a Working Party of the Hospital Infection
Society", 1990, Journal of Hospital Infection, 15, pp. 7-34. .
Sanders, et al., "Outer Gloves in Orthopaedic Procedures", 1990,
The Journal of Bone and Joint Surgery, Inc., 72-A[6], pp. 914-917.
.
Closs & Tierney, "Theatre Gowns: A Survey of the Extent of User
Protection", 1990, Journal of Hospital Infection, 15, pp. 375-378.
.
Mandlebort, et al., "A Survey of Exposure, Practices and
Recommendations of Surgeons in the Care of Patients with Human
Immunodeficiency Virus", 1990, Surgery--Gynecology &
Obstetrics, vol. 171, No. 2, pp. 99-106. .
Henderson, et al., "Risk of Occupational Transmission of Human
Immunodeficiency Virus Type 1 (HIV-1) Associated with Clinical
Exposures", 1990, Annals of Internal Medicine, vol. 113, pp.
740-746. .
Beekmann, et al., "Risky Business: Using Necessarily Imprecise
Casualty Counts to Estimate Occupational Risks for HIV-1
Infection", 1990, Infection Control Hospital Epidemiology, 11[7],
pp. 371-379. .
Bloomfield, et al., "Evaluation of Hypochlorite-Releasing
Disinfectants Against the Human Immunodeficiency Virus (HIV)",
1990, Journal of Hospital Infection, 15, pp. 273-278. .
Johnson, et al., "Efficacy of Glove Combinations in Reducing Cell
Culture Infection After Glove Puncture With Needles Contaminated
With Human Immunodeficiency Virus Type 1", 1991, Infection Control
and Hospital Epidemiology, 12[7], pp. 435-438. .
Panlilio, et al., "Blood Contacts During Surgical Procedures",
1991, Journal of American Medical Association, 265[12], pp.
1533-1537. .
Gross, "Many Doctors Infected with AIDS Don't Follow New U.S.
Guidelines", 1991, The New York Times, vol. CXL . . . No. 48,696,
p. 1. .
Orentlicher, "HIV-Infected Surgeons: Behringer v. Medical Center",
1991, The Journal of American Medical Associations, 266[8], pp.
1134-1137. .
Zanowiak, "Skin Infections: The Role of OTC Therapy", Jun. 1991,
U.S. Pharmacist pp. 40-47. .
Mast, "Factors Predicting Infectivity Following Needlestick
Exposure to HIV: A Invitro Model", 1991, Clinical Research, 39(1):
p. 58A. .
Wright, "Mechanicms of Glove Tears and Sharp Injuries Among
Surgical Personnel,"1991, Journal of American Medical Association,
266(12): 1668-1671. .
Boscia, Peterson, Szpalski, Panlilio & Gerberding, Letters to
the Editor: "Surgery, AIDS, and Hepatitus B", 1991, Journal of
American Medical Association, 266(10): 1360-1362. .
Belkin, L. Apr. 7, 1992 New York Times, ppA1 & B2: "Fear of
Disease Changing How Doctors Work". .
Associated Press, Apr. 14, 1992 New York Times, ppC3: "Teen-Agers
and AIDS: The Risk Worsens.". .
Remington's Pharmaceutical Sciences, 13th Edition, 1965, pages
455-459, pp. 525-556, and pp. 1228-1252: "Suspensions", Chapter
37--Medicated Applications, and Chapter 74--Antimicrobial Drugs.
.
Remington's Pharmaceutical Sciences, 18th Edition, 1990, pp.
1163-1241: "Antimicrobial Drugs"..
|
Primary Examiner: Crowder; Clifford D.
Assistant Examiner: Current; Sara M.
Claims
We claim:
1. A flexible protective glove with a liquid-impermeable wall
having the capability to provide a liquid antiseptic composition
treatment to a hand and to a hand wound should the wound occur
underneath the glove while the glove is being worn when a wall of
the glove is punctured by an object that may be contaminated with
an infectious pathogen, comprising:
(a) a glove wall with a liquid-impermeable outer layer comprised of
a first material having a thickness of about 1 mil to about 40 mils
and a liquid-impermeable less elastic inner layer composed of a
second material having a thickness of about 0.3 mils to about 30
mils wherein the first material and the second material form the
walls of a compartment capable of containing a liquid antiseptic
composition;
(b) the liquid antiseptic composition in the compartment which
comprises an antiseptic in a liquid;
(c) the glove wall capable of providing a physical barrier as a
means of protective to the hand while the glove is being worn by an
individual until a portion of the glove wall is punctured by an
object;
(d) the glove wall capable of being punctured by the object while
the glove is being worn on the hand;
(e) the glove wall having the flexibility to allow the hand of an
individual in need of wearing the glove to easily and adequately
perform delicate, dexterous and complex work including the work
performed by a surgeon, a medical doctor, a dentist, a laboratory
worker, a health care worker, a law enforcement worker, a hospital
worker, and other workers;
(f) the glove having the capability to provide a coating to at
least a portion of the object puncturing the glove wall; the
coating comprising the liquid antiseptic composition; the coating
on the object providing a means for immediately transferring some
of the liquid antiseptic composition onto the hand and into the
hand wound by the object puncturing the glove wall while the glove
is being worn; the liquid antiseptic composition transferred to the
hand and to the hand wound having the capability to provide an
immediate liquid antiseptic composition treatment to the hand and
hand wound;
(g) the glove having the additional capability to leak some of the
liquid antiseptic composition from a section of the glove wall
having a hole resulting from the object puncturing the glove wall;
the hole in the outer layer may shrink while the hole in the less
elastic inner layer of the glove is not as capable of contracting
to a small size; the liquid antiseptic composition leaking from the
hole having the capability of flowing onto the hand and into the
hand wound as a means for providing a treatment of liquid
antiseptic composition to the hand and to the hand wound; more
liquid antiseptic composition may leak from the glove wall onto the
hand and into the hand wound than from the glove wall onto the
outer surface of the glove; and
(h) the glove having the capability of treating the hand and the
hand wound with the liquid antiseptic composition when the object
punctures the glove wall, when the object contacts the hand, when
the object may wound the hand, and when the object may contaminate
the hand and the hand wound with the infectious pathogen; wherein
the liquid antiseptic composition transferred to the hand and the
hand wound can help to protect the hand, the hand wound, and the
systemic circulation of the individual by killing, inactivating,
and otherwise destroying the infectious pathogen that may be
contaminating the hand and the hand wound.
2. The glove according to claim 1, wherein the liquid antiseptic
composition is capable of being redistributed within the
compartment of the glove by massaging the glove to force the liquid
antiseptic composition in the compartment to accumulate near the
glove wall having the hole and to leak at an increased rate from
the wall having the hole onto the hand and into the hand wound
providing additional liquid antiseptic composition to treat the
skin and the hand wound resulting in additional protection of the
skin and hand wound from the infectious pathogen that may be
contaminating the skin and the hand wound.
3. A glove according to claim 1, wherein the first material and the
second material comprise:
(a) a structural material selected from the group consisting of
latex rubber, cis-1,4-polyisoprene, cis-polybutadiene, neoprene
rubber, nitrile rubber, silicone rubber, cellulose acetate plastic,
vinyl plastic, polyethylene plastic, polypropylene plastic,
polyvinyl chloride plastic, polyvinyl acetate plastic, polystyrene
plastic, polymethyl methyl-acrylate plastic, polyacrylonitrile
plastic, vinyllite plastic, saran plastic, polytetrafluoroethylene
plastic, polytrifluorochloroethylene plastic, polycaprolactam
plastic, polyester plastic, urea formaldehyde plastic, polyurethane
plastic, isotactic polypropylene plastic, nylon plastic, rayon
plastic, polyamide plastic, phenolic plastic, silicone plastic,
silk fiber, cotton fiber, cellulose fiber, wool fiber, animal skin,
animal intestinal tissue, animal connective tissue, metallic fiber,
mineral fiber and mixtures thereof.
4. A glove according to claim 3, wherein the first material
comprises: a structural material selected from the group consisting
of latex rubber, cis-1,4-polyisoprene rubber, cis-polybutadiene
rubber, neoprene rubber, and nitrile rubber, silicone rubber and
mixtures thereof; and wherein the second material comprises: a
structural material selected from the group consisting of cellulose
acetate plastic, vinyl plastic, polyethylene plastic, polypropylene
plastic, polyvinyl chloride plastic, polyvinyl acetate plastic,
polystyrene plastic, polymethyl methylacrylate plastic,
polyacrylonitrile plastic, vinyllite plastic, saran plastic,
polytetrafluoroethylene plastic, polycaprolactam plastic, rayon
plastic, polytrifluorochloroethylene plastic, nylon plastic,
polyester plastic, urea formaldehyde plastic, polyurethane plastic,
isotactic polypropylene plastic, polyamide plastic, phenolic
plastic, silicon plastic, silk fiber, cotton fiber, plant fiber,
wool fiber, animal skin, animal intestinal tissue, animal
connective tissue, metallic fiber, mineral fiber, and mixtures
thereof.
5. A glove according to claim 1, wherein the antiseptic is selected
from the group consisting of chlorhexidine gluconate, chlorhexidine
acetate, sodium dichloroisocyanurate, octoxynol, nonoxynol-9,
ethanol, isopropanol, propanol, benzyl alcohol, allyl alcohol,
methanol, sodium hypochlorite, potassium hypochlorite, hypochlorous
acid, acetic acid, trichloroacetic acid, benzoic acid, sodium
benzoate, boric acid, sodium borate, lactic acid, chloramine,
elemental iodine, sodium iodide, potassium iodide, calcium iodide,
ammonium iodide, ferrous iodide, strontium iodide, lithium iodide,
magnesium iodide, zinc iodide, silver iodide, selenium iodide,
povidone-iodine, formaldehyde, glutaraldehyde, mercurous chloride,
zinc nitrate, zinc sulfate, zinc oxide, zinc acetate, zinc
chloride, silver nitrate, silver sulfadiazine, hydrogen peroxide,
benzoyl peroxide, phenol, sodium phenolate, cresol, methylphenol,
resorcinol, orthophenylphenol, chloroxylenol, hexyl-resorcinol,
parachlorophenol, para-tertiaryamylphenol, thymol, butylparaban,
ethylparaben, methylparaben, propylparaben, triclosan,
o-benzyl-p-chlorophenol, hexachlorophene, poloxamer 188,
benzalkonium chloride, benzethonium chloride, cetylpridinium
chloride, econazole, methylbenzethonium chloride,
cetyldimethylbenzylammonium chloride, triclocarban, clotrimazole,
ciclopirox olamine, undecylenic acid, miconazole, tolnaftate, and
mixtures thereof.
6. A glove according to claim 1, wherein the liquid medium is
selected from the group consisting of water, methanol, ethanol,
isopropanol, propanol, allyl alcohol, butanol, isobutanol,
sec-butanol, tert-butanol, benzyl alcohol, 2-octyl dodecanol,
glycerol, propylene glycol, a polyethylene glycol of about 150 to
about 600 molecular weight, urea, acetone, methyl ethyl ketone,
ethyl ketone, methyl isopropyl ketone, 2-pentanone, ethyl acetate,
ethyl propionate, ethyl butyrate, ethyl valerate, methyl acetate,
propyl acetate, buryl acetate, pentyl acetate, isopentyl acetate,
benzyl acetate, mineral oil, silicone oil, hexamethyl disiloxane,
glycerol trioctanoate, decyl oleate, cetearyl isononanoate,
dimethicone, perfluropolymethyisopropyl ether of about 1500 to
about 6600 molecular weight, olive oil, cottonseed oil, corn oil,
soybean oil, wheat germ oil, linseed oil, pine oil, almond oil,
macadamia oil, coconut oil, jojoba oil, peanut oil, persia oil,
castor oil, cod liver oil, shark liver oil, mink oil, squalene and
mixtures thereof.
7. A glove according to claim 1, wherein the liquid antiseptic
composition contains a surface-active agent to facilitate the
coating of the object with the liquid antiseptic composition, the
surface active agent selected from the group consisting of
dodecyldimethylamine oxide, lauryldimethylamine oxide, stearic
acid, dibutyl adipate, octyl stearate, sodium cetearyl stearate,
isopropyl myristrate, palmitic acid, stearyl alcohol, colloidal
magnesium aluminum silicate, caprylic triglyceride, capric
triglyceride, cetostearyl alcohol, decyl-beta-D-glucopyranoside,
nonyl-beta-D-glucopyranoside, octylbeta-D-glucopyranoside,
triethanolamine stearate, sodium lauryl sulfate,
heptyl-beta-D-glucopyranoside, hexyl-beta-D-glucopyranoside,
dodecyl-beta-D-maltoside, decyl-beta-D-maltoside, sodium
dodecylsulfate, sodium oleate, potassium laurate, sodium laurate,
sodium lauryl sulfate, glycerol monostearate, propylene glycol
monostearate, bis(2-ethylhexyl)sodium sulfosuccinate,
N-octylsulfobetaine, propylene glycol monolaurate,
N-dodecylsulfatobetaine, octyl-beta-D-thioglucopyranoside,
heptyl-beta-D-thioglucopyranoside, N-dodecyl-N,N-dimethylglycine,
cetyl alcohol, N-decylsulfatobetaine, digitonin,
N-hexyldecylsulfatobetaine, N-tetradecylsulfatobetaine, dioctyl
sodium sulfosuccinate, N,N,bis(3-D-gluconamidopropyl)-cholamide,
sodium deoxycholate, N,N,bis(3-D-gluconamidopropyl)-deoxycholamide,
glycerol monostearate, sodium taurodeoxycholate, sodium cholate,
sodium taurocholate, sodium glycocholate, cetyltrimethylammonium
bromide, 3-[(3-cholamidopropyl)dimethylammonio]-1-propanesulfonate,
3-[(3-cholamidopropyl)dimethylammonio]-2-hydroxypropane-1-sulfonate,
octanoyl-N-methylglucamide, nonanoyl-N-methylglucamide,
decanoyl-N-methylglucamide, nonyl-N-methylglucamide, lecithin,
lysolecithin, nonaethylene glycol monododecyl ether, nonaethylene
glycol octylphenol ether, nonaethylene glycol octylcyclohexyl
ether, heptaethylene glycol octylphenyl ether, heptaethylene glycol
octylcyclohexyl ether, polyoxyethylene (10) monolauryl ether,
polyoxyethylene (8) isotridecyl ether, polyoxyethylene (10)
isotridecyl ether, polyoxyethylene (15) isotridecyl ether,
polyoxyethylene (9) lauryl ether, polyoxyethylene (23) lauryl
ether, octaethylene glycol monododecyl ether, nonaethylene glycol
monododecyl ether, polyethylene polypropylene glycol, sorbitan
monopalmitate, sorbitan monooleate, sorbitan monostearate,
polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan
monooleate, polyoxyethylene-4-lauryl ether, a polyethylene glycol
of about 150 to about 600 molecular weight, polyethylene glycol 400
monostearate, polyoxyethylene-4-sorbitan monolaurate,
polyoxyethylene-20-sorbitan monooleate, polyoxyethylene-20-sorbitan
monopalmitate, polyoxyethylene-20-sorbitan monolaurate,
polyoxyethylene-40-stearate, dimethicone, simethicone,
dimethylpolysiloxane, sorbitan trioleate, sorbitan tristreate,
propylene glycol monostearate, sorbitan sesquioleate,
diphenylmethylsilicone, lauryldimethylbenzylammonium chloride, a
perfluropolymethylisopropyl ether of about 1500 to about 6600
molecular weight, acacia, type A gelatin, type B gelatin, egg yolk
phospholipids, soybean phospholipids, cholesterol, colloidal
aluminum silicate, colloidal magnesium hydroxide, and mixtures
thereof.
8. A glove according to claim 1, wherein the liquid antiseptic
composition contains an algesic agent to increase the pain
sensation perceived from the hand, to alert the individual when the
hand has been wounded, the algesic agent selected from the group
consisting of formic acid, acetic acid, hydrochloric acid,
phosphoric acid, sodium hydrogen phosphate, sodium phosphate,
potassium hydrogen phosphate, potassium phosphate, citric acid,
sodium hydrogen citrate, sodium citrate, sulfuric acid, sodium
hydrogen sulfate, sodium sulfate, sodium hypochlorite, potassium
hypochlorite, bradykinin, substance P, bee venom, wasp venom, ant
venom, potassium chloride, potassium citrate, potassium sulfate,
potassium phosphate, potassium carbonate, potassium bromide,
potassium iodide, potassium fluoride, potassium hydroxide,
potassium nitrate, and mixtures thereof.
9. A glove according to claim 1, wherein the liquid antiseptic
composition further contains a colorant as a means for providing a
colored visual signal to the individual when and where the glove
wall has been punctured by the object, the colorant selected from
the group consisting of a dye, an iron oxide, titanium dioxide, and
mixtures thereof.
10. A glove according to claim 1, wherein the liquid antiseptic
composition further contains a vasoconstricting agent in a
concentration of about 1 vasoconstricting agent part in 200,000
parts of the liquid antiseptic composition to about 1
vasoconstricting agent part in 2,000 parts of the liquid antiseptic
composition as a means for reducing blood flow in the hand wound as
a means for reducing a systemic spreading of the infectious
pathogen in the individual, the vasoconstricting agent selected
from the group consisting of epinephrine, norepinephrine,
phenylephrine, ephedrine, metaraminol, methoxamine, and mixtures
thereof.
11. A glove according to claim 1, wherein the liquid antiseptic
composition further contains a viscosity-modifying polymer as a
means for adjusting the viscosity of the liquid antiseptic
composition to between about 1 centipoise and about 5000 centipoise
at a temperature of between about 10 to about 45 degrees
centigrade, the viscosity-modifying polymer selected from the group
consisting of xantham gum, gum acacia, gum tragacanth, agar,
glycyrrhiza, sodium alginate, cellulose, methyl cellulose,
carboxymethylcellulose sodium, glycerol, propylene glycol,
pyroxylin, polyoxyethylene glycols of about 150 to about 600
molecular weight, gelatin, dimethicone of about 100 to about 1000
centistokes viscosity, simethicone, dimethylpolysiloxane,
perfluropolymethyl-isopropyl ether of about 1500 to about 6600
molecular weight, starch, and mixtures thereof.
12. A glove according to claim 1, wherein a structural connection
is made by using a third material to connect the first material to
the second material, the third material comprising:
(a) a structural material selected from the group consisting of
latex rubber, cis-1,4-polyisoprene rubber, cis-polybutadiene
rubber, neoprene rubber, nitrile rubber, silicone rubber, cellulose
acetate plastic, vinyl plastic, polyethylene plastic, polypropylene
plastic, polyvinyl chloride plastic, polyvinyl acetate plastic,
polystyrene plastic, polymethyl methylacrylate plastic,
polyacrylonitrile plastic, vinyllite plastic, saran plastic,
polytetrafluoroethylene plastic, polytrifluorochloroethylene
plastic, nylon plastic, rayon plastic, polycaprolactam plastic,
polyester plastic, urea formaldehyde plastic, polyurethane plastic,
isotactic polypropylene plastic, polyamide plastic, phenolic
plastic, silicone plastic, silk fiber, cotton fiber, plant fiber,
wool fiber, animal skin, animal intestinal tissue, animal
connective tissue, metallic fiber, mineral fiber, a glue comprising
at least one of the aforementioned structural materials, and
mixtures thereof.
13. A glove according to claim 12, wherein the structural
connection reconfigures the compartment storing the liquid
antiseptic composition into a plurality of compartments capable of
storing the liquid antiseptic composition.
14. A glove according to claim 1, wherein the liquid antiseptic
composition comprises:
(a) about 0.02 to about 20 parts of povidone-iodine,
(b) about 0.1 to about 90 parts of water,
(c) about 0.05 to about 30 parts of a polyethylene glycol of about
150 to about 600 molecular weight, and
(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
15. A glove according to claim 1, wherein the liquid antiseptic
composition comprises:
(a) about 0.1 to about 20 parts of elemental iodine,
(b) about 0.1 to about 20 parts of sodium iodide
(c) about 0.1 to about 30 parts of water,
(d) about 0.05 to about 30 parts of a polyethylene glycol of about
150 to about 600 molecular weight, and
(e) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
16. A glove according to claim 1, wherein the liquid antiseptic
composition comprises:
(a) about 0.1 to about 35 parts of sodium hypochlorite,
(b) about 50 to 99 parts of water,
(c) about 0.05 to about 30 parts of a polyethylene glycol of about
150 to about 600 molecular weight, and
(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
17. A glove according to claim 1, wherein the liquid antiseptic
composition comprises;
(a) about 0.1 to about 25 parts of chlorhexidine gluconate,
(b) about 0.1 to about 90 parts of water,
(c) about 0.05 to about 30 parts of a polyethylene glycol of about
150 to about 600 molecular weight, and
(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
18. A glove according to claim 1, wherein the liquid antiseptic
composition comprises;
(a) about 0.1 to about 50 parts of nonoxynol-9,
(b) about 0.1 to about 95 parts of water,
(c) about 0.05 to about 30 parts of a polyethylene glycol of about
150 to about 600 molecular weight, and
(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
19. A method of using a flexible protective glove with a
liquid-impermeable wall on a hand of an individual to protect the
hand in the event that an object contaminated with an infectious
agent punctures the glove, may wound the hand and may contaminate
the hand and the hand wound with the infectious pathogen,
comprising the steps of:
(a) using the glove initially as a liquid-impermeable physical
barrier to infectious pathogens; using the glove to permit the hand
to perform a delicate, dexterous and complex type of work that
includes the type of work performed by a surgeon, medical doctor, a
dentist, a laboratory worker, a hospital health care worker, a law
enforcement worker, and a hospital worker; and storing a liquid
antiseptic composition in the glove wall;
(b) using the object to puncture the glove wall;
(c) using the glove to coat a portion of the object puncturing the
glove wall with the liquid antiseptic composition when the object
punctures the compartment storing the liquid antiseptic
composition;
(d) using the object puncturing the glove to transfer a portion of
the coating of the liquid antiseptic composition on the object, to
the hand and into the hand wound when the object contacts the
hand;
(e) using the glove wall having the hole formed by the object as a
means for leaking more liquid antiseptic composition from the glove
wall onto the hand and into the hand wound than from the glove wall
onto the outer surface of the glove;
(f) controlling the relative size of the holes in the outer and
inner glove layers to bias the direction of liquid antiseptic
composition from the glove so that most of the leakage occurs
across the inner glove layer onto the hand and into the hand wound
rather than across the outer glove layer by selecting a material
composition for the inner glove layer that is less elastic than the
material composition selected for the outer glove layer; and
(g) using the liquid antiseptic composition transferred from the
glove to the hand and to the hand wound to kill, to inactivate, and
to otherwise destroy the infectious pathogen that may have been
transferred to the skin and into the hand wound by the object.
20. A flexible protective glove with a liquid-impermeable wall
having the capability to provide a liquid antiseptic composition
treatment to a hand and to a hand wound should the wound occur
underneath the glove while the glove is being worn when a wall of
the glove is punctured by an object that may be contaminated with
an infectious pathogen, comprising:
(a) a glove wall with a liquid-impermeable outer layer comprised of
a first material having a thickness of about 1 mil to about 40 mils
and a liquid-impermeable inner layer composed of a second material
having a thickness of about 0.3 mil to about 30 mils wherein the
first material and the second material form the layers of a
compartment capable of storing a liquid antiseptic composition;
(b) the liquid antiseptic composition which contains a
vasoconstrictive agent;
(c) the glove wall capable of providing a physical barrier as a
means of protection to the hand while the glove is being worn by an
individual; the glove wall capable of being punctured by the
object;
(d) the glove having the flexibility to allow the hand of the
individual wearing the glove to easily and adequately perform
delicate, dexterous and complex work including the work performed
by a surgeon, medical doctor, a dentist, a laboratory worker, a
health care worker, a law enforcement worker, a hospital worker and
like workers;
(e) the glove having the capability to provide a coating of liquid
antiseptic composition to at least a portion of the object
puncturing the glove wall; the coating of liquid antiseptic
composition on the object providing a means for immediately
transferring some liquid antiseptic composition onto the hand and
into the hand wound contacted by the object; the liquid antiseptic
composition transferred to the skin and to the hand wound having
the capability to help to provide an immediate treatment of liquid
antiseptic composition to the hand and to the hand wound;
(f) the glove having the additional capability of leak some of the
liquid antiseptic composition from a section of the glove wall
having a hole resulting from the object puncturing the glove wall;
the liquid antiseptic composition leaking from the hole having the
capability to flow onto the hand and into the hand wound as a means
for providing a treatment of liquid antiseptic composition to the
hand and to the hand wound; and
(g) the glove having the capability to help to treat the hand and
the hand wound with a liquid antiseptic composition when the object
punctures the glove wall, when the object may contact, when the
object may wound the hand, and when the object may contaminate the
hand and the hand wound with the infectious pathogen; wherein the
liquid antiseptic composition transferred to the hand and to the
hand wound has the capability to help to protect the hand, the hand
wound and the systemic circulation of the individual by killing,
inactivating, and otherwise destroying the infectious pathogen that
may contaminate the hand and the hand wound.
Description
FIELD OF THE INVENTION
The present invention is a flexible protective medical glove that
relates to the thin-walled medical glove that doctors, health care
workers and other workers can wear on one or both hands as a
physical barrier form of protection; in particular the present
invention is a glove containing a liquid antiseptic composition
within the glove wall; the liquid antiseptic composition comprises
an antiseptic in a liquid.
No useful medical glove is puncture-proof; when an individual wears
a conventional medical glove, the thin glove wall can readily be
punctured by an object and the hand underneath the glove may become
wounded. If the object is contaminated with an infectious pathogen,
then the hand and the hand wound may become contaminated and the
individual may suffer a systemic pathogenic infection. A glove in
accordance with the present invention can help to prevent the hand
and the hand wound contamination from causing a systemic infection;
such a glove is urgently needed in medical work environments
harboring the AIDS virus, hepatitus B virus, and other infectious
pathogens. When an object punctures a glove in accordance with the
present invention, the object can become coated with the liquid
antiseptic composition. If the object in the process causes a hand
wound, some liquid antiseptic composition can be carried into the
hand wound; useful as an immediate liquid antiseptic composition
treatment of the contaminated hand and hand wound. Once punctured,
the glove wall can also leak the liquid antiseptic composition onto
the hand and into the hand wound as an means for the treatment. In
addition, the gloved hand can be immediately massaged to
redistribute the liquid antiseptic composition in the glove wall
towards the puncture hole in the glove, to increase the rate of
liquid antiseptic composition leakage.
BACKGROUND OF THE INVENTION
In general, disposible latex gloves are worn during a medical
procedure to provide a physical barrier between a patient's body or
tissues and the hands and wrists of a health care practicioner such
as a physician, nurse, phlebotomist and the like. The gloves need
to be flexible so that the manual dexterity of the health care
practicioner or worker is not significantly decreased. The gloves
are well-fitting and are comfortable so that glove wear does not
cause hand fatigue or discomfort.
Sterile and nonsterile latex medical gloves are available. Sterile
latex medical gloves are also known in the field as surgical
gloves; they are sterilized at the glove factory; are made
available typically as a pair in a specific size and are sealed in
a sterile package. Surgical gloves are most often used for sterile
field surgery to prevent a transfer of an infectious pathogen to a
surface of a surgical wound from a surgeon's hands. Nonsterile
latex medical gloves are also known in the field as examination
gloves; they are used during non-sterile procedures; are made
available usually in a size that can suitably fit either hand and
are often packaged in bulk, for example in quanities of 50 per box.
Non-sterile procedures include the medical examination of human
body surfaces, body invaginations and body orifaces; nonsterile
medical gloves are also worn for protecting the hands of medical,
research or hospital workers from contact with biohazardous
substances and surfaces which include but are not limited to the
following: biological waste products such as feces and urine,
soiled wound dressings, garments or other materials, irritating or
toxic liquids or chemicals, biological toxins, radioactive
substances, and infectious pathogens. For the present invention,
the term "infectious pathogens" is meant to include but is not
limited to the following: viruses, bacteria, fungi, rickettsia,
prions, multicellular parasites, the spores of infectious
pathogens, and the like.
At least three kinds of glove wall failure are known currently
plague the currently known types of medical gloves. First, about
two percent of standard latex gloves have inherent microscopic
perforations from manufacturing that can be permeated by the
smaller infectious pathogens such viruses. Secondly, during their
use, medical gloves may acquire small tears, perforations or
punctures which go unnoticed and provide a means for infectious
pathogens, particularily in bloody contaminated body fluids, to
come into contact with the hands of the glove wearer. If an
infectious pathogen contacts human skin, the individual may
eventually become systemically infected with the pathogen. Thirdly,
a gloved hand may become contaminated with an infectious pathogen
if the glove is accidentally punctured by an object that is
contaminated with an infectious pathogen. The glove puncturing
object may have a sharp edge like a hypodermic needle, suture
needle, or scapel blade or may only have blunt edges. Clearly the
currently available medical gloves are not designed to protect a
hand from becoming contaminated with an infectious pathogen once
the glove wall has become damaged. The breakdown of the physical
barrier protection of a glove leaves a hand susceptible to
contamination and infection with an infectious pathogen, and
ultimately susceptible to a systemic infection with the pathogen
which may have devastating consequences.
The recent emergence of several lethal vital diseases caused by
infectious pathogens has created an urgent need for more protective
medical gloves that retain their medical utility. Currently, the
most feared infectious pathogen is the human immunodeficiency virus
(HIV); this infectious pathogen is believed to systemically infect
and compromise the human immune system and thereby cause Acquired
Immune Deficiency Syndrome (AIDS); AIDS generally is ultimately
fatal. Hepatitis B virus is another example of a lethal virus that
infects humans.
Medical gloves are commonly made from elastomeric or plastic
materials such as latex rubber or plastic. Materials for a glove
may also be obtained from a plant fiber such as cotton, animal
secretion such as silk, animal tissue such as the skin or
intestine, a mineral fiber or a metal fiber. The material(s) used
to manufacture a medical glove should be flexible and should be
capable of being made into a fiber or a thin sheet.
A second pair of gloves may be worn over the first pair of gloves
to increase the thickness of their physical barrier protection.
Multiple pairs of medical gloves can be worn provided that fine
dexterous hand work can still be done. If two or more pairs of
gloves are worn, the medical work by the gloved hand may become
difficult and tiring.
Thick-walled work gloves have been made from the same materials
used to make thin-walled gloves. Thick-walled gloves are inflexible
and this property has generally limited their utility to most
medical doctors, health care workers, skilled workers and like
workers. A number of thick-walled work gloves have been developed
to protect a hand from a serious cut or puncture wound by an
object. For example, thick-walled cut-resistent gloves have been
developed to protect the hands in animal slaughter houses where
meat is manually cut (See U.S Pat. No. 4,526,828 and PCT WO
91/10409). However, a puncture-resistent glove has not been
developed that is also flexible enough for medical personnel and
the like.
A glove in accordance with the present invention is designed to be
thin-walled and flexible, to be comfortably worn and easily used by
medical personnel and the like workers; consequently a glove in
accordance with the present invention is Just as capable as a
standard medical glove of being punctured by an object. But the
present invention has important, novel additional functions. A
glove in accordance with the present invention can immediately
begin to help to protect a hand and a hand wound beneath the glove
from becoming infected with an infectious pathogen after an object
contaminated with an infectious pathogen has punctured the
glove.
A recent study of accidental blood contact during hospital surgical
procedures in burn, trauma, orthopedic, general, gynecology, and
plastic surgical services concluded that surgical gloves are an
important means for preventing a substantial percentage of the
blood contacts with the hands (Panlilo et al, 1991). Blood and body
fluids can be contaminated with infectious pathogens such as the
human immunodeficiency virus (HIV, also commonly called the AIDS
virus) and the Hepatitis B virus. Because many substances or
material objects can temporarily harbor an infectious pathogen,
medical workers are well-schooled in the risks of becoming
contaminated from contacting soiled objects and body fluids from
infected individuals. Medical workers are advised to wear medical
gloves in any environment which may contain infectious pathogens
(Panlilo et al., 1991).
The United States Center For Disease Control (U.S. CDC) has issued
guidelines for the prevention and control of nosocomial infections,
for hospital environment control, and for control of surgical wound
infections (See publications by Simmons, B. P., 1983). The U.S. CDC
reported that a clean wound (a wound that is initially
pathogen-free) has only a 1 to 5 percent average risk of becoming
infected; the U.S. CDC reported that a contaminated wound (a wound
exposed to an infectious pathogen) has a 15 to 17 percent average
risk of becoming infected, and that a dirty wound (a wound exposed
to biological or environmental liquid and solid waste which may be
contaminated with an infectious pathogen) has more than a 27
percent average risk of becoming infected. Therefore, an infection
is more likely to occur in a dirty or contaminated wound than in a
clean wound. Surgeons have administered an antiseptic solution
directly into a wound as an irrigation solution (See also Maki, D.
C, 1976). Furthermore the U.S. CDC guidelines have advised doctors
and health care workers to wash their hands with an antiseptic
detergent to reduce the microbial (infectious pathogen)
contamination on their hands before they wear medical gloves. Wound
cleaning and antiseptic decontamination of the hands are thus
established methods for decreasing the risk of infection in a
wound. The U.S. CDC has also reported that antiseptics are more
effective antimicrobial agents than soap and water, but has pointed
out that frequent skin contact with an antiseptic can be more
irritating than soap and water to the skin.
In 1987, the U.S. CDC issued the recommendation that medical
examination gloves be worn as a "universal precaution". To adhere
to the universal precaution guidelines, doctors and other medical
personnel are expected: (1) to assume that each patient is infected
with human immunodeficiency virus (HIV) and thus to wear a new pair
of gloves with each new patient, and (2) to remove their gloves and
to wash their hands immediately if their hands appear to have
become contaminated with blood or other body fluids (See Bartlett,
J. G., 1988).
Although medical workers are well aware of the utility of an
antiseptic in the prevention of skin infection and wound infection,
medical glove wearers may not always be able to comply with the
proposed U.S. CDC guidelines in a competent manner. It may be
inconvient or impossible for a glove wearer to immediately remove a
damaged or contaminated glove during surgery or during a stressful
medical emergency. Such a delay in glove removal may be dangerous
for the glove wearer. The time delay may permit the blood
circulation of the glove wearer to become more contaminated with an
infectious pathogen. Later attempts to disinfect the hand or hand
wound with an antiseptic would then be ineffective in preventing
the systemic infection of the individual with the infectious
pathogen. The individual may also delay glove removal and cleaning
the contaminated hand or hand wound with an antiseptic because the
accident went unnoticed; the pain of the wound pain may not be not
felt and/or hand wound bleeding may be minor or not seen. Thus,
delayed glove removal and delayed hand disinfection wearer can have
serious consequences.
There has been an obvious increase in the wearing of medical gloves
in many health care work environments following adoption of the
"universal precautions" guidelines and the epidemic growth of AIDS
in the human population. To be safe, because it is not known for
certainty exactly which work environments can harbor an infectious
pathogen such as HIV, medical gloves are now routinely worn by many
medical or public workers when they feel they are at some risk of
accidental infection. The work environments or forms of work may
include but are not limited to the following examples: hospitals,
medical clinics, private doctor offices, emergency medical
ambulance work, fire rescue work, medical practice areas involving
AIDS patient care, surgery, gynecology, human fertility work,
urology, general medicine, pathology, epidemiology, microbiology,
neurology, orthopedics, radiology, oncology, nursing, dentistry,
podiatry, psychiatry, psychiatric hospitals, hospices, other
medical practices and specialties, kidney dialysis centers,
diagnostic medical imaging-testing and operations facilities,
hospital emergency waiting rooms, emergency hospital ambulatory
care, clinics for drug rehabilitation, donor organ and tissue
preservation banks and labs, blood banks, blood testing and related
analytical chemistry labs, sperm banks, sperm testing labs, basic
and clinical medical research labs, medical instrument cleaning,
sharpening and repair facilities, hospital patient rooms, operating
rooms, cleaning and maintenance work, hospital laundaries, hospital
cafeterias, other hospital patient food service work, hospital
morgues, funeral homes and related work areas dealing with study
and handling of dead human bodies and tissues, medical and public
waste or refuse collection areas, disposal areas and containers for
human blood and disposible medical utensils, work with blood
products, urine products or other body products, hospital trash and
other disposible waste areas which might contain medical waste,
work with sharp contaminated objects such as needles, syringes,
wires, catheters, and intravenous sets, plastic and glass tubes and
pipettes, glass slides, scalpel blades, and the like; disposible
medical instruments and work areas involved in surgical instrument
handling, repair and cleaning, clothing and medical assist areas;
areas of medical garbage removal and medical sanitation work,
medical work in retirement homes, and cleaning or industrial
operations in any building where there may be any risk of a
pathogenic infection. Surgical gloves and/or examination gloves
(medical gloves) may be used in animal medicine and during general
work with animals in research, on farms or ranchs with animals, in
veterinary and animal husbandry practices and pet stores, in work
with zoo animals, and in similar work where there may be some risk
of contact with an infectious pathogen. Medical gloves may also
provide useful protection from physical contact with infectious
pathogens that may exist in potentially infectious nonmedical
technical areas, scientific areas and other work areas including
the following: industrial, military, or other research work that
involves work with pathogens in molecular biology or molecular
genetics, fermentation and vaccine production; the facilitites
include any government, military, commercial, industrial, or
biotechnological production, research and testing areas. Medical
gloves are also useful protective hand wear in areas or in work
which may include the following: public and business building
maintenance work and cleaning, outdoor public areas work,
restaurant work, sports clubs, spas, health clubs, massage palors,
ghetto area building rehabilitation and clean-up work; guard work
in jails, prisons, and other crimminal confinement facilities.
Public or private vehicles used to provide surface, underground,
water, underwater, air, aerospace or even outer space transport
conceivably may harbor infectious pathogens. Travel in such
vehicles may require an individual to wear protective medical
gloves.
Conventional medical gloves are often worn to protect the hands of
an individual from coming into physical contact with an infectious
pathogen that infects another individual. The following individuals
at risk of being infected with an infectious pathogen are listed
here as a nonlimiting example: a person infected with the AIDS
virus, a person infected with hepatitus B virus or other viruses, a
person with a bacterial infection, a hospital patient, a health
care patient, an intravenous drug user, a prostitute, a gang
member, a homeless person, a mentally-ill person, a person
suspected of or engaged in criminal activity, a captured or
convicted or imprisoned crimminal; an illegal immigrant, an
immigrant from an AIDS infested population, a new immigrant, a
homosexual or bisexual individual, a sexually promiscuous
individual, and a chronically-ill, elderly or incapacitated person
who is at an increased risk of harboring an infectious
pathogen.
A glove in accordance with the present invention may also usefully
protect an individual under other circumstances. Animals, plants,
soil, water, the air, and various forms of environmental pollution
are capable of supporting colonies of infectious pathogens which
may infect an individual. Thus workers in many nonmedical
environments can also be contaminated by an infectious pathogen;
such nonmedical workers include but are not limited to the
following workers: law enforcement workers, police, state trooper,
national guard, military personnel, traffic police, transit police,
jail and prison workers, park workers and park cleaners, sanitation
workers, city morgue workers, hospital morgue workers, funeral home
workers, and cemetary workers, waste and water treatment facility
workers, street cleaners, sewer workers and other municipal
workers, persons cleaning public bathrooms and portable toilet
maintainance workers.
In addition, gloves in accordance with the present invention can be
worn by any doctor, dentist, health care worker and the like or
other individual who choses to continue working after they have
tested seropositive with an infectious pathogen such as HIV or
hepatitus B virus (See News York Times article by Jane Gross, dated
Aug. 18, 1991). It is particularly important for infected medical
personnel to wear protective medical gloves so that they do not
transmit their infection via their hands to another person.
If an object cuts, or otherise penetrates a thin medical glove wall
while it is being worn on a hand, the physical barrier protection
provided by the glove is immediately lost. Such an accident to a
glove may in the process also wound the hand and this wounding can
expose the blood circulation of the individual to an infectious
pathogen; becoming wounded is particularly traumatic if the surface
of the wounding object is thought to be contaminated with an
infectious pathogen such as HIV.
Medical personnel in particular know that a conventional medical
glove can not adequately protect the hand it covers from a
hand-wounding accident with an AIDS-contaminated object such as a
syringe needle. A variety of medical objects have caused an instant
HIV inoculation to the hands of health care workers wearing
standard surgical or examination gloves (See Henderson et al.,
1990; Beekman et al., 1990; Panlilo et al., 1991).
For the present invention, the term glove wall puncture is defined
broadly to encompass glove wall punctures caused by any process. A
glove wall puncture may be caused by any physical object capable of
cutting, biting, abrading, puncturing, stabbing, crushing, or
otherwise physically penetrating the glove wall. When such objects
are contaminated with an infectious pathogen, they can act as a
carrier for the transfer of the infectious pathogen to the hand and
the hand wound. Alternatively, the glove wall puncture may be
caused in the absence of a solid physical object, by one or more of
the following processes: a chemical reaction with the glove, a
solvent that can dissolve the glove wall, a change in the ambient
gas pressure or liquid pressure over the glove wall, a powerful
electrical shock through the glove wall, a thermal melting or
burning of the glove wall or a low temperature fragmentation of the
glove wall; in these examples, the process causing the glove wall
puncture may not act as a carrier for the transfer of an infectious
pathogen to the hand or the hand wound. In general however, a glove
wall puncture creates the access means for an infectious pathogen
to contact the hand or a hand wound from the exterior surface of
the glove.
Health care workers and medical doctors in particular, know that
hand wounding is a common accident that they often experience a
number of times each year in their work environments because
conventional medical gloves are not puncture-resistant (Panlilio et
al., 1991; see especially Wright et al., 1991). For the present
invention, the term "hand" is herein broadly defined to encompass
all portions of an arm and a hand that may be covered by a glove in
accordance with the present invention; thus use of the term "hand"
may refer to the fingers, all surfaces of the hand, the wrist, the
forearm, and may refer even to the surfaces of the arm up to the
armpit and shoulder for some embodiments of the present
invention.
Health care workers and other professionals who care for patients
with AIDS know that they can become infected with the AIDS virus
(HIV) from the AIDS patients. It is important to consider that as a
result of the AIDS epidemic, medical doctors and health care
workers now work with increased anxiety and fear of contracting
AIDS; that an accidental hand wound during their professional work
may infect them with HIV and shorten their lives (Gerberding and
Schecter, 1991). Each time a gloved hand is wounded by an object
contaminated with blood or other body fluids, the wounded medical
worker must psychologically deal with the possibility that the
wound was contaminated with HIV, that the medical worker may be at
risk of a systemic HIV infection. Thus, there is a particularily
urgent need for an improved medical glove that can better protect a
hand when the hand is wounded by an object that may be contaminated
with an infectious pathogen such as HIV.
Some medical doctors and health care workers have been reluctant to
admit that they have obtained a hand wound during their work from
an object possibly contaminated with HIV or that their blood has
tested positive for HIV antibodies because this information may
indicate that they may have a systemic HIV infection. Such
disclosures can threaten their employment in health care (See
Orentlicher, D., 1991; and New York Times article by Jane Gross,
dated Aug. 18, 1991). As a result of the unreported HIV infections,
the data gathered to estimate the incidence of accidental skin
punctures among health care workers is undoubtedly underestimated
and thus inaccurate.
As already mentioned, sharp medical instruments and needles in use
by medical personnel can easily puncture a standard medical glove
on a hand and the hand underneath the glove can become wounded (See
Gerberding and Schecter, 1991). The reported incidence of
accidental skin punctures to hospital surgical personnel in three
major municipal hospitals (in San Francisco, Albuerque, and
Atlanta) has averaged 2 to 5 injuries per 100 procedures (Panlilio
et al., 1991; Gerberding et al., 1990; Gerberding and Schecter,
1991). These hospitals have also reported that occupational
exposure to blood occurred often in surgical settings (Gerberding
et al., 1990; Gerberding and Schecter, 1991; Panlilio et al.,
1991). Accidental blood contact between a patient having HIV and
workers in other more casual (nonsurgical) medical settings has
been predicted to increase in view of the epidemic spread of HIV
infection in the United States and in the World (Gerberding et al.,
1990).
Three known factors that can affect the risk of a medical worker
becoming infected with an infectious pathogen are (1) the
prevalence of blood-borne infection in the patient population under
treatment by the medical worker, (2) the frequency and types of
hazardous exposure that the medical worker is subjected to, and (3)
the risk of infection that accompanies each exposure to the medical
worker (Gerberding and Schecter, 1991). It thought unlikely that
medical personnel can control the first two factors and still
remain valid health care workers. It is an object of the present
invention to lower the worker's risk from the third factor, namely
a glove in accordance with the present invention can lower the risk
of infection that accompanies each hazardous exposure to a medical
worker's hand.
The risk of systemic HIV infection to an individual wounded on a
hand from a single hollow needle stick has recently been estimated
to average roughly 0.4 percent (1 occurence in 250 events). This
risk estimate was calculated from observations of documented
needlestick wounds that were contaminated with blood from patients
having an advanced stage of HIV infection during which their blood
had an elevated HIV titer (Beekman et al., 1990; Henderson et al.,
1990). This estimate is obviously an underestimate because some
hand injuries will not be reported and therefore this study
underscores the real risk medical workers experience.
Analysis of the risk of infection that accompanies each individual
exposure of the hand and the hand wound to an infectious pathogen
has been conducted, based upon an in vitro study of glove wall
punctures by needles. The study found that the risk was influenced
by several variables. An important variable was the volume of
infectious blood transferred by the needlestick (See Mast and
Gerberding, 1991). Other important variables included (1) the titer
of the infectious pathogen in the contaminating blood, (2) the
needle type and size, and (3) the depth of skin penetration by the
pathogen contaminated object. Other observations have shown that
wearing a standard medical glove on the hand can reduce the volume
of blood transferred to the hand wound by about 50 percent (See
Gerberding and Schecter, 1991). When two pairs of standard medical
gloves were worn on the hand, the contamination of the hand wound
by blood was further reduced to between 20 to 40 percent,
(Gerberding and Schecter, 1991; Mandelbrot et al., 1990). Thus,
studies have found that wearing two gloves on a hand can not
adequately protect a hand, as it is wounded by a blood-tainted
needle, from becoming contaminated with a substantial fraction of
the foreign blood, infectious pathogens or other substances present
on the blood-tainted needle. In view of the (a) marginal protection
that conventional gloves can provide, (b) the frequency of
accidental hand wounds by gloved health care workers, and (c) the
increasing incidence of HIV infection in the human population, it
is reasonable to expect that the probability of any health care
worker becoming infected with HIV during work as a result of HIV
contamination of a hand wound will increase. Because almost every
HIV infection eventually causes AIDS which is believed to be fatal
for almost all individuals, the medical profession is greatly
concerned that the risk of HIV infection from a medical glove
puncture is too high and urgently needs to be substantially reduced
(See Orentlicher, 1991).
A glove capable of providing an immediate liquid antiseptic
composition treatment to a hand or a hand wound would be a novel
invention. The prior art has not disclosed a glove having a wall
storing or leaking a liquid antiseptic composition which comprises
an antiseptic in a liquid. The prior art has not disclosed the use
of a glove capable of storing a liquid antiseptic composition or
capable of leaking the liquid antiseptic composition onto a hand or
into a hand wound as a treatment means for the hand and the hand
wound when the glove is punctured and/or the hand is wounded by an
object that may be contaminated with an infectious pathogen. To
have medical utility, such a protective medical glove would need to
retain the flexibility and the comfortability characteristics of
conventional medical gloves. A glove in accordance with the present
invention can meet these requirements but has not been identically
disclosed or described in the prior art. Related prior art is
described below but is not identical to the present invention. In
view of the prior art, the subject matter of the present invention
as a whole would not be obvious to persons of ordinary skill in the
art pertaining to the subject matter of the present invention at
the time of the invention.
A protective gel composition has been disclosed (U.S. Pat. No.
5,019,604 issued May 28, 1990 to G. M. Lemole) for coating the skin
prior to covering the hands with standard surgical gloves. In one
example, the composition contains lanolin, liquid silicone,
polypropylene glycol monoleate, polytetrafluoroethylene powder in
microspherical form, zinc oxide powder, anti-bacterial agents and
antiviral agents with a preferred agent being nonoxynol-9. The
composition forms a water repellent coating on the skin to prevent
the skin contacting body fluids such as blood and blood products
that may penetrate the gloves and otherwise expose the skin to
harmful microbial and vital infections. The use of a protective gel
to continuously contact the skin with chemicals may be irritating
to the hands. After glove removal, the gel coating the skin must be
washed off. Some individuals may also find that the number of step
required to use and remove the gel is disagreeable. Use of the gel
composition in a liquid composition in between two gloves was not
suggested.
Use of antiseptic-coated gloves has been disclosed in a study of
surgical hand hygiene (J. Hospit. Infect. 1988, 11 Supp. A:244-250
by Newsom et al.). Gloves were coated with solid cetylpyridinium
chloride and surpressed skin flora counts after prolonged
operations in comparison to standard gloves, but the solid
antiseptic coating may cause hand irritation after prolonged
contact. Use of such antiseptic in a liquid composition in between
two gloves was not suggested.
Use of the antiseptic 4.0% chlorhexidine gluconate detergent
formulation containing 4.0% isopropyl alcohol (Hibiclens/Hibiscrub)
and the antiseptic 0.50% chlorohexidine gluconate in 70.0%
isopropyl alcohol with emollients (Hibistat/Hibisol) as a skin
treatment has been disclosed (J. Hospital Infection, 1990,
15:279-282 by Montefiori DC et al.). This antiseptic composition
was found to inactivate HIV in experimental cell cultures after 15
seconds when used at 1:100 and 1:5 dilutions. Use of such
antiseptic in liquid composition in between two gloves was not
suggested.
A sterile glove has been disclosed in which the antibacterial agent
zeolite is immobilized in a plastic film on one or both surfaces of
the glove; useful for handling food, for work in a kitchen or for
medical purposes (U.S. Pat. No. 5,003,638 issued Apr. 2, 1991 by T.
Miyake and T. Yamamoto). According to the Merck Index (8th
Edition), zeolite is a hydrated dust or powder of alkali aluminum
silicate. An immobilized thin layer of antibacterial agent can not
help to prevent a hand wound infection. Use of such antiseptic in
liquid composition in between two gloves was not suggested.
A glove has been disclosed which was made by first immobilizing an
anti-microbial agent into rubber and by then solidifying the
mixture into a glove (U.S. Pat. No. 5,031,245, issued Jul. 16, 1991
by Milner, R.). The glove was reported to be an improved barrier to
HIV. A non-ionic, sparingly water-soluble antimicrobial agent that
does not coagulate natural rubber latex such as chlorophene,
dichloroxylenol, hexachloraphane was used; diphenyl derivatives may
be halogenated and used such as 0.1% to 10% by wt.
2,4,4'-trichloro-2'-hydroxyphenyl ether, diacetylaminoazotoluene,
triclocarban and triclosan. The surface of the glove was dusted
with a powder containing an antimicrobial agent such as
chlorhexidine digluconate and cyclodextrin. The antiseptic dust on
the glove surface contacts the hand while the glove is worn and may
irritate the skin. Use of such antiseptic in liquid composition in
between two gloves was not suggested.
A multilaminar hybrid glove has been disclosed having at least an
outer rubber layer, an inner rubber layer and at least one
intermediate cotton material layer impregnated with a gel
containing nonoxynol-9; regions of the glove may be protected with
an armor of fungicide-coated, puncture-resistant Kevlar plastic
(Infect. Control Hospital Epidemiol. 1991 12(7): 435-438 by Johnson
et al., 1991). In vitro tests found that the glove with Kevlar
resisted some needlestick punctures. In vitro tests found that the
glove reduced the transfer of HIV from a solid needle tip to a
culture dish by chemical inactivation of the virus on the needle
when the needle contacted the gel containing nonoxynol-9 in the
cotton layer. Results using "hollow" syringe needles were not
obtained and the authors indicated they could not predict such
results without additional study. The multilaminar glove was stiff
and thick walled, and therefore was useless as a flexible
protective glove for a hand that had to be able to comfortably
perform medical tasks. The use of nonoxynol-9 in a liquid
composition stored between two medical gloves was not
suggested.
The present invention is directed to providing novel protective
glove designs and methods for their use. A glove in accordance with
the present invention contains within its glove walls a liquid
antiseptic composition which comprises an antiseptic in a liquid.
The subject matter of this invention as a whole has not been made
obvious nor was it suggested by either the prior art concerning
protective medical gloves or the prior art concerning protective
antiseptic compositions for the hands. The flexible protective
medical gloves which comprise the present invention solve the
problem of protecting a gloved hand from an infection when the
glove is punctured and the hand underneath the glove is wounded by
an object contaminated with an infectious pathogen. The method of
using the present glove invention is simple because the substantial
protective functions of the glove are semi-automated; thus the
present invention is an important advancement in the medical glove
field because the a glove in accordance with the present invention
can help to immediately treat an infectious pathogen contaminated
hand and hand wound with a liquid antiseptic composition provided
that the contamination has arisen from the act of a glove
puncturing object while the glove is being worn. A further
advantage of the present invention over the prior art is that
contact and thus unnecessary irritation of the hand by the
antiseptic composition is avoided until the glove wall is punctured
by an object.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a flexible
protective medical glove having a thin glove wall comprising at
least an outer glove layer of a first material having a thickness
of between about 1 mil (1 mil is one-thousandth of an inch) to
about 40 mils and at least an inner glove layer of a second
material having a thickness of between about 0.3 mils to about 30
mils wherein the first material and the second material form at
least the walls of a compartment storing a liquid antiseptic
composition. The compartment storing the liquid antiseptic
composition generally has a thickness ranging between about 10 mils
to about 100 mils, but in some areas of the glove, particularily
while the glove is being worn, it is imagined that the compartment
could become temporarily compressed to less than 1 mil in
thickness; alternatively or at the same time the compartment in
some areas of the glove may be expanded by design or while the
glove is being worn could become temporarily expanded to a
thickness exceeding 500 mils. At the end of the glove where the
hands would be first inserted, the compartment may be open or may
be closed. Alternatively, the glove may be capable of being
reversibly opened or closed using for example a zip-lock or sealing
seam between the glove layers at the opening of the compartment, to
allow the individual that wears the glove to increase or reduce the
amount of liquid antiseptic composition in the glove. Preferably
the compartment is closed. A glove in accordance with the present
invention can be as flexible a conventional medical glove; this is
needed to permit the gloved hand to easily and adequately perform
delicate, dexterous and complex hand work including for example,
the hand work of a surgeon, a medical doctor, a dentist, a
laboratory worker, a health care worker, a law enforcement worker,
a hospital worker and like workers. It is conceivable that the
glove wall can be constructed from almost any material or
combination of materials provided that at least the surface of the
inner glove layer and at least the surface of the outer glove layer
are liquid-impermeable. Most preferably the glove wall layers are
made using thin flexible layers of rubber and/or plastic
materials.
The liquid antiseptic composition comprises an antiseptic in a
liquid. Preferably the liquid antiseptic composition contains at
least one of the following antiseptics: povidone-iodine, elemental
iodine, sodium iodide, potassium iodide, sodium hypochlorite,
nonoxynol-9, and chlorhexidine gluconate in a liquid such as
ethanol, water, isopropanol, or a mixture of the liquids thereof.
Preferably the liquid antiseptic composition further includes at
least one surface active agent. The liquid antiseptic composition
may also contain one or more of the following substances: an
organic silicone, an organic solvent, a salt, an acid, a base, a pH
buffer, a preservative that can help to stabilize the antiseptic
activity, a metal ion chelator, a sticky chemical additive or a
viscosity-modifying agent that can help to increase the coating of
the glove puncturing object with the liquid antiseptic composition,
a chemical scent that can help to increase the smell or render the
odor of the liquid antiseptic composition more pleasant, an
emulsifier and/or a foaming agent that can help to better mix the
liquid antiseptic composition with the contaminants on the hand and
in the hand wound containing infectious pathogen, glycerin, a soap,
a detergent, an algesic agent (a pain-causing agent), a coloring
agent, or a vasoconstricting agent.
The present invention also provides a new method of protecting a
gloved hand from an infectious pathogen in the event of glove
damage while the glove is being worn.
It is another object of the present invention to also provide
methods for the use of the present invention. Gloves in accordance
with the present invention, like standard medical gloves, can
provide a useful thin physical barrier form of protection to the
hands. It an object of the present invention to minimize contact
between the hand and the liquid antiseptic composition to reduce
unnessary irritation of the hand by the antiseptic until such time
that the wall of the glove is punctured by an object, and the
antiseptic must contact the hand. When an object punctures the thin
walls of the glove, it is an important object of the present
invention to immediately begin to treat the hand and the hand wound
should the wound occur, with a liquid antiseptic composition.
The treatment of liquid antiseptic composition from the glove
should be capable of inactivating, killing, and/or otherwise
destroying the infectious pathogen that the liquid antiseptic
composition may contact. The liquid antiseptic composition should
be capable of disabling the contacted infectious pathogen so that
the infectious pathogen is no longer dangerous to the hand and the
hand wound of the contaminated individual. For the present
invention, the term "infectious pathogen" has a broad meaning
intended to encompass known and yet to be discovered pathogenic
microorganisms including prions and viruses as well as the
biochemical cofactors or molecular fragments that can be
synthesized or released by an infectious pathogen or other
biological cells or may arise by other biosynthetic means; the term
is intended to include biochemical cofactors and chemical fragments
including but not limited to the following: deoxyribonucleic acids
(DNA), ribonucleic acids (RNA, mRNA, tRNA and the like), protein
cofactors, and the enzymes that act upon DNA, RNA, mRNA, tRNA and
like nucleic acids in any form or conformation which may alter the
potency of a pathogenic infection. The nonhuman proteins that help
HIV to inhibit the human immune system are considered to be protein
cofactors and fall under the term infectious pathogen as it is
employed by the present invention. Some of these proteins may
affect the binding of HIV to human cells. Damage to these proteins
by the liquid antiseptic composition can have an anti-infective
utility. Thus, the term "infectious pathogen" for the present
invention is broadly meant to include at least the following
infectious pathogens in all forms of their existence: viruses,
bacteria, yeasts, molds, algae, other fungi, multicellular
parasites, rickettsia, prions, the spores of infectious pathogens,
and any of the biochemical molecular fragments of an infectious
pathogen (i.e., DNA, the various RNA molecules, associated DNA and
RNA enzymes and associated proteins) that can contribute to the
infectivity of an infectious pathogen.
For some embodiments of present invention, it is an important
object that the liquid antiseptic composition have potent antiviral
or viricidal activity against the human immunodeficiency virus
(HIV), and/or the Hepatitis B virus.
An object of the present invention is to help to protect the hand
and the hand wound should the wound occur, from becoming infected
by a glove puncturing object that is contaminated with an
infectious pathogen. When the glove wall is punctured by an object,
the object may in the process also wound the hand and come into
contact with the blood circulation of the individual. In passing
through the glove wall, the object can become coated with liquid
antiseptic composition and can carry some liquid antiseptic
composition along with the infectious pathogen contamination to the
hand and into the hand wound, useful as an immediate liquid
antiseptic composition treatment to the hand and the hand wound
that can help to immediately protect the individual from developing
a systemic infection with the infectious pathogen.
Another object of the present invention is to have the punctured
glove wall leak liquid antiseptic composition from the puncture
hole in the glove wall. The liquid nature of the liquid antiseptic
composition is a novel and important property of the present
invention. A liquid antiseptic composition can flow onto the hand
and into the hand wound; useful as a means for providing a liquid
antiseptic treatment to the hand and the hand wound that can begin
to help to protect the individual from a systemic infection with
the infectious pathogen.
In one embodiment according to the present invention, the glove is
comprised of a liquid-impermeable outer layer of a first material
and a liquid-impermeable inner glove layer of a second material
wherein the first material and the second material form the walls
of a compartment capable of containing a liquid antiseptic
composition; the compartment contains or stores the liquid
antiseptic composition which comprises an antiseptic in a liquid
medium. The glove also has the capability to provide a coating to
at least a portion of the object puncturing the glove wall; the
coating comprising the liquid antiseptic composition; the coating
on the object providing a means for immediately transfering some of
the liquid antiseptic composition onto the hand and into the hand
wound resulting from the object puncturing the glove wall while the
glove is being worn; the liquid antiseptic composition transferred
to the hand and the hand wound having the capability to provide an
immediate liquid antiseptic composition treatment to the hand and
the hand wound areas that may be contaminated with the infectious
pathogen transferred from the object. The glove has the additional
capability to leak some of the liquid antiseptic composition from a
section of the glove wall having a hole resulting from the object
puncturing the glove wall; the liquid antiseptic composition
leaking from the hole having the capability of flowing onto the
hand and into the hand wound as a means for providing a liquid
antiseptic composition treatment to the hand and to the hand wound
that may be contaminated with the infectious pathogen. The glove
has the further capability of treating the hand and the hand wound
with a liquid antiseptic composition when the object punctures the
glove wall, when the object contacts the hand, when the object may
wound the hand and when the object may contaminate the hand and the
hand wound with the infectious pathogen; wherein the liquid
antiseptic composition transferred from the glove to the hand and
the wound on the hand can help to protect the hand, the hand wound,
and the systemic circulation of an individual by killing,
inactivating and/or otherwise destroying the infectious pathogen
that may be contaminating the hand and the hand wound.
In a second embodiment according to the present invention, the
glove contains a liquid antiseptic composition which is also
capable of being redistributed within the compartment of the glove
by massaging the glove to force the liquid antiseptic composition
in the compartment to accumulate near the glove wall having the
hole caused by the glove-puncturing object. As a result, the liquid
antiseptic compostion can leak at an increased rate from the
punctured glove wall having the hole onto the hand and into the
hand wound; the additional liquid antiseptic composition contacting
the hand and the hand wound can provide additional protection to
the hand, the hand wound, and the systemic circulation of an
individual from an infectious pathogen that may be contaminating
the hand and the hand wound as a result of the contact of the hand
and hand wound by the glove-puncturing object.
In another embodiment according to the present invention, the glove
contains a liquid antiseptic composition which may also contain a
pain-causing chemical such as a potassium salt, bradykinin or
substance P. An object of the pain-causing chemical is to provided
enhanced pain sensation at the hand wound to better warn the glove
wearer that they may have suffered a hand wound.
According to another embodiment of the present invention, the glove
contains a liquid antiseptic composition which may also contain a
colored substance such as a dye or an opacifier to help visually
signal when and where a glove wall has been punctured. It is an
object of the present invention to alert and to protect the glove
wearer, particularily an overly stressed glove wearer, of glove
damage that might otherwise be missed.
According to another embodiment of the present invention, the glove
contains a liquid antiseptic composition which may also contain a
chemical capable of producing a distinctive chemical smell or odor
which can be either bad smelling or pleasant smelling. Sudden
release of a distinctive chemical odor from a gloved hand or glove
is a useful means for increasing a glove wearer's awareness that a
glove may be damaged.
According to another embodiment of the present invention, the glove
contains a liquid antiseptic composition which may also contain a
vasoconstricting agent; preferably a catecholamine such as
epinephrine or norepinephrine. An object of the vasoconstricting
agent is to constrict blood flow in the hand wound area as a means
for limiting the systemic dispersion of the infectious pathogen
from the hand wound by the blood circulation or by the lymphatic
circulation of the gloved individual.
According to another embodiment of the present invention, the glove
contains a liquid antiseptic composition which may also contain a
viscosity-modifying agent to alter the physical flow properties of
the liquid antiseptic composition; this additive can be
particularily useful as a means for increasing the thickness of the
coating of liquid antiseptic composition on the glove-puncturing
object.
According to another embodiment of the present invention, the outer
surface layer of the glove wall is comprised of an elastic material
such as a rubber material; and the inner surface layer of the glove
wall is comprised of a plastic material. After a glove puncture has
occurred and the object has been removed from the glove wall, the
hole in the elastic outer layer of the glove may shrink while the
hole in the less-elastic inner layer of the glove is not as capable
of contracting to a small size due to glove layer material
properties. Thus, more liquid antiseptic composition may leak from
the glove wall onto the hand and into the hand wound than from the
glove wall onto the outer surface of the glove.
According to another embodiment of the present invention the glove
wall has a plurality of glove layers acting as a structural
connection which reconfigures the compartment storing the liquid
antiseptic composition into a plurality of compartments capable of
storing the liquid antiseptic composition. This can be useful as a
means for selectively partitioning the liquid antiseptic
composition in the glove wall.
According to another embodiment of the present invention, the glove
wall comprises a sponge-like wall structure capable of acting as a
structural connection which reconfigures the compartment storing
the liquid antiseptic composition into a plurality of compartments
capable of storing the liquid antiseptic composition; the outer and
inner surfaces of the glove wall are coated with a
liquid-impermeable coating of a rubber or a plastic material. The
actual number of pore-sized compartments, the degree of
segmentation of the glove wall into the compartments, and the
volume of each subcompartment is not critical and may be highly
variable.
According to another embodiment of the present invention, the
compartment storing the liquid antiseptic composition is subdivided
into a number of smaller compartments as a means for controlling
the distribution and capacity for redistribution of the liquid
antiseptic composition within the glove wall. Each smaller
compartment may be connected to another small compartment by at
least one hole so that liquid antiseptic composition can flow
between the small compartments. Some of the subdivided compartments
may be closed.
According to another embodiment of the present invention, the
compartment storing the liquid antiseptic composition is subdivided
into a plurality of closed compartments as a means for controlling
the distribution of the liquid antiseptic composition within the
glove wall.
According to another embodiment of the present invention, the
compartment of the glove storing liquid antiseptic composition is
connected to an additional resevoir of liquid antiseptic
composition whose flow can be regulated by a one-way flow
valve.
The subject matter which we regard as our invention is more
particularily pointed out and distinctly claimed in the concluding
portion of this specification. Other features and advantages are
inherent in the protective glove and method claimed and disclosed
for its use or will become apparent to those skilled in the art
from the following detailed description in conjunction with the
accompanying diagrammatic drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1A is a perspective view and a partial enlarged view
illustrating a glove containing a liquid antiseptic composition
between an outer layer of a first material and the inner layer of a
second material in accordance with the present invention;
FIG. 1B is a partial enlarged view of the section of a glove wall
shown circled in FIG. 1A;
FIG. 2A is an enlarged sectional view of a glove wall taken along
line 5--5 in FIG. 1A, illustrating one edge of an object which is
puncturing a glove in accordance with the present invention; in
this example, the object is puncturing the glove wall along Line
5--5 and the liquid antiseptic composition in the glove wall is
coating the object;
FIG. 2B illustrates the situation of FIG. 2A at a later point in
time, after a portion of the object has fully punctured the glove
wall and has then wounded the hand; in the process liquid
antiseptic composition coating the object has been transferred to
the hand and hand wound as an antiseptic treatment to the hand and
to the hand wound;
FIG. 2C illustrates the situation of FIG. 2B at a later point in
time, after the object has been removed from the punctured glove;
liquid antiseptic composition is leaking onto the hand and into the
hand wound from the hole left in the glove wall by the object;
FIG. 2D illustrates the situation of FIG. 2C at a later point in
time, after the damaged glove has been massaged; the massage
causing increased liquid antiseptic composition to accumulate in
the glove wall near the hole in the glove, the accumulation
increasing the leak of liquid antiseptic composition from the glove
hole to the hand and the hand wound;
FIG. 3 illustrates a perspective view of a glove in accordance with
the present invention, and a partial expanded view of a finger and
a partial expanded view of the wrist area; the compartment storing
liquid antiseptic composition is enlarged in the wrist area of the
glove;
FIG. 4 illustrates a perspective view of a glove in accordance with
the present invention with a partial expanded view of the glove
wall; the glove has several structural connections between the
innner layer and the outer layer of the glove.
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1A illustrates a glove in accordance with the present
invention; the glove indicated generally at 1 is composed of
flexible materials forming a liquid-impermeable wall having the
capability to provide a liquid antiseptic composition treatment to
a hand and to a hand wound underneath the glove while the glove is
being worn when the wall of the glove is punctured and/or when the
hand is wounded by an object that may be contaminated with an
infectious pathogen.
It is an object of the present invention to provide a glove having
any conceivable arm length, up to and including a glove having an
arm length that can protect the entire arm of an individual up to
about the shoulder region of the individual. Whereas the normal
length of the glove is between about 6 inches and about 12 inches,
the arm-length glove could be as long as 36 inches.
A glove in accordance with the present invention can be made
sufficiently elastic so that one size glove may be worn on
different sized hands; in this aspect the glove would be analogous
to the conventional medical examination glove. Alternatively, a
glove in accordance with the present invention can be made in
different sizes so that the glove does not need to be substantially
stretched and unduly stressed in order to closely fit the hand; in
this respect the glove would fit the hand closely like a
conventional medical surgical glove.
FIG. 1B is an enlarged view of a representative section of the
glove wall shown circled in FIG. 1A. FIG. 1B illustrates that the
glove wall comprises an outer layer 2 of a first material and an
inner layer 3 of a second material. The first material and the
second material form the walls of a compartment 4 capable of
containing or storing a liquid antiseptic composition.
A glove in accordance with the present invention contains a liquid
antiseptic composition in compartment 4. Liquid antiseptic
composition is symbolized in all Figures by stippling the area in
the Figure with dots. The liquid antiseptic composition comprises
an antiseptic in a liquid. Some antiseptics which are liquids may
serve in the liquid antiseptic composition as both the antiseptic
and the liquid component; an example would be the use of an
alcohol.
It is another object of the present invention to provide a glove
wall capable of providing a physical barrier as a means of
protecting the hand while the glove is being worn by an individual.
The glove provides a useful physical barrier until a portion of the
glove wall is punctured by an object. When a glove in accordance
with the present invention is worn on the hand of a working
individual such as a surgeon, a medical doctor, health care worker,
or other worker, the glove wall should be sufficiently flexible
that the the gloved hand can easily and adequately perform
delicate, dexterous and complex work.
It is another object of the present invention to provide the method
of using a flexible protective glove with a liquid-impermeable wall
on a hand of an individual to protect the hand in the event that an
object contaminated with an infectious agent punctures the glove,
may wound the hand and may contaminate the hand and the hand wound
with the infectious pathogen, comprising the steps of:
(a) using the glove initially as a liquid-impermeable physical
barrier to infect ious pathogens; using the glove to permit the
hand to perform a delicate, dexterous and complex type of work that
includes the type of work performed by a surgeon, a medical doctor,
a dentist, a laboratory worker, a hospital health care worker, a
law enforcement worker, and a hospital worker; and storing a liquid
antiseptic composition in the glove wall;
(b) using the glove to coat a portion of an object puncturing the
glove wall with the liquid antiseptic composition when the object
punctures the compartment storing the liquid antiseptic
composition;
(c) using the object puncturing the glove to transfer a portion of
the coating of the liquid antiseptic composition on the object, to
the hand and into the hand wound when the object contacts the
hand;
(d) using the glove wall having the hole formed by the object as a
means for leaking the liquid antiseptic composition onto the hand
and into the hand wound; and
(e) using the liquid antiseptic composition fro the glove that is
on the hand and in the hand wound to kill, to inactivate, and to
otherwise destroy the infectious pathogen transferred to the skin
and into the hand wound by the object.
It is another object of the present invention to provide a glove
that can be worn to protect an individual from an infectious
pathogen; such a glove is particularily useful for a worker who
ordinarily needs to wear a pair of standard medical or surgical
gloves to protect their hands during their work. Gloves in
accordance with the present invention can provide superior
protection compared to conventional medical gloves. The present
invention should be particularily useful for medical personnel such
as doctors, surgeons, dentists, laboratory workers, health care
workers, and other hospital workers; the gloves should be
especially useful for individuals handling an AIDS infected patient
or Hepatitis B infected patient.
FIG. 2A, FIG. 2B, FIG. 2C, and FIG. 2D illustrate another object of
the present invention: how the glove can function during an
accidental glove puncture by an object while the glove is being
worn on a hand. Like a standard medical examination glove or
surgical glove, a glove in accordance with the present invention is
thin-walled and is capable of being punctured by an object if
adequate force is applied by the object against the glove wall. For
the present invention, the definition of a glove-puncturing object
includes objects capable of puncturing, tearing, penetrating,
cutting, abrading, shredding, biting, or otherwise disrupting the
physical integrity of the glove wall to such a degree that a
portion of the glove wall is no longer liquid-impermeable. As
mentioned already, the wounding of a gloved hand by a
glove-puncturing object is surprisingly common, particularily to
health care workers. The glove puncturing object may be either
blunt or sharp edged. Frequently cited objects causing accidental
glove puncture have included hypodermic syringe needles, suture
needles, scapel blades, mechanical devices, medical instruments,
blunt forceps, hemostats, glass slides and accessory medical
objects such drill tips, chisels, saws, wires and glass objects.
The edge of the glove-puncturing object depicted in FIG. 2A, FIG.
2B, FIG. 2C, and in FIG. 2D is sharp. A sharp object is depicted
here only for illustrative purposes and is not meant to be a
limiting example. The glove puncturing object could well be a
blunt-edged object. The interactions illustrated in the Figures
between the glove-puncturing object 6, glove layer 2, glove layer
3, the liquid antiseptic composition 4 and hand 8 would be
approximately the same for any glove-puncturing object, as will
become readily apparent from the following detailed description of
these interactions.
FIG. 2A illustrates a cross-section of a glove wall along Line 5--5
as shown in FIG. 1A. A glove-puncturing object 6 is puncturing a
glove on a hand 8 at a glove wall puncture 10. Object 6 may be
contaminated with blood, other body fluids, other solids and
mixtures therof. In addition, object 6 may be contaminated with an
infectious pathogen. The contamination of the glove-puncturing
object 6 is not been depicted in these Figures. The three arrows in
FIG. 2A indicate the direction of motion for object 6. The contact
angle of object 6 with the glove wall is not critical for function
of the present invention.
It is another object of the present invention to provide a coating
7 of liquid antiseptic composition onto the puncturing portion of
object 6. When object 6 punctures an outer glove layer 2 and
contacts a compartment 4 storing the liquid antiseptic composition,
object 6 can obtain a coating 7 of liquid antiseptic
composition.
It is another object of the present invention to transfer a portion
of coating 7 from object 6 to the space between inner glove layer 3
and hand 8. In FIG. 2B, object 6 has completely punctured the glove
wall by puncturing inner glove layer 3. Coating 7 of liquid
antiseptic composition on object 6 may then flow off object 6 into
the space between inner glove layer 3 and hand 8.
It is another object of the present invention to transfer a portion
of coating 7 to a hand wound 9, should the wound occur: wounding
can be caused in the process of the continued motion of object 6
into the surface of hand 8. Depending upon the depth of penetration
of object 6 into the hand, the hand wound 9 may be shallow or deep.
Prior to contacting the gloved hand, object 6 may have been
contaminated; the contaminant may include an infectious pathogen,
blood, other body fluids, other solids and mixtures thereof. The
infectious pathogens transferred from object 6 to hand 8 or hand
wound 9 may cause a hand infection and/or a systemic infection. As
discussed, the risk of an infection in the gloved individual may be
lowered significantly by immediately treating the hand and the hand
wound with a liquid antiseptic composition. A contamination of hand
8 or hand wound 9 by object 6 can be particularily hazardous for
example if object 6 was contaminated with HIV or Hepatitis B virus.
Thus, one method by which a glove in accordance with present
invention functions is by using the glove puncturing object as a
means for transferring some liquid antiseptic composition to the
hand and to hand wound at the same time that the object may be
transferring an innoculum of an infectious pathogen to the hand and
into the hand wound caused by the glove-puncturing object. This
function of the present invention can help to provide an immediate
treatment of liquid antiseptic composition to the hand and to the
hand wound and thereby help to prevent the establishment of a
pathogenic systemic infection in the gloved individual as a result
of the glove puncture.
It is another object of the present invention as illustrated in
FIG. 2C, to have glove wall puncture 10 function to leak liquid
antiseptic composition from compartment 4 after object 6 has been
removed from the glove wall. Some leakage of liquid antiseptic
composition from the compartment may take place before the glove
puncturing object is actually removed from the glove. However,
liquid antiseptic composition can flow more rapidly through inner
glove layer 3 using the hole left by puncture 10 and can flow then
onto hand 8 and into hand wound 9. This leak of liquid antiseptic
composition can be used to further treat hand 8 and hand wound 9 to
help to prevent the development of a pathogenic systemic infection
therein.
It is another object of the present invention as illustrated in
FIG. 2C, to enable the glove wearer or any other individual
observing the gloved hand to more quickly see puncture site 10 and
where the leak of liquid antiseptic composition arises out through
outer glove layer 2 when the glove is damaged. To accomplish this
objective, the liquid antiseptic composition may contain a
color&hr. The colorant may consist of one or more dyes and/or
one or more opacifiers or any combination therein. Some nonlimiting
examples of the colorants that could be used in the liquid
antiseptic composition include one or more of the following dyes:
FD&C Yellow No.5, FD&C Yellow No.6, D&C Yellow No.10,
FD&C Red No.3, FD&C Red No.40, D&C Red No.28, D&C
Red No.30, D&C Red No. 33, FD&C Blue No.1, FD&C Blue
No.2., FD&C Green No.3, D&C Green No.5, yellow iron oxide,
black iron oxide, red iron oxide, brown iron oxide, and mixtures
thereof or another acceptable dye. The colorant may be combined
with one or more of the following opacifiers: white titanium
dioxide, white calcium carbonate, white zinc sulfate, white zinc
oxide, yellow iron oxide, black iron oxide, red iron oxide, brown
iron oxide, and mixtures thereof or another acceptable opacifier.
The location of the glove leak may also be used to help to quickly
determine where and if the hand underneath the glove has been
wounded.
Another object of the present invention is to have a smaller hole
in outer glove layer 2 than in inner glove layer 3, after the
glove-puncturing object has been removed from glove wall at
puncture 10. This particular objective of the present invention has
been depicted in FIG. 2C. The relative difference in the size of
the puncture holes in the glove layers may be optimized in part by
selecting a material composition for inner glove layer 3 that is
less elastic and more plastic (and thus more capable of bursting
and irreversibly tearing when punctured) than the material
composition selected for outer glove layer 2. Controlling the
relative size of the holes in the outer and inner glove layers can
help to bias the direction of the leakage of the liquid antiseptic
composition from the glove so that most of the leakage through
puncture 10 occurs across inner glove layer 3 onto hand 8 and into
hand wound 9, rather than across outer glove layer 2.
It is another object of the present invention to provide a
prophylactic treatment of liquid antiseptic composition to the hand
and to the hand wound should the wound occur when a glove wall
puncture 10 is caused by an object whether or not the object is
known to be contaminated with an infectious pathogen. The treatment
can be an immediate and effective method for helping to prevent an
infection to the hand, the hand wound, and the systemic circulation
of an individual. The liquid antiseptic composition transferred to
the hand and the hand wound can flow over the hand and into the
hand wound. The liquid nature of the liquid antiseptic composition
is extremely useful; the liquid permits the antiseptic to mix
initimately with the biological contamination and infectious
pathogen that is present on glove-puncturing object 6 and
transferred by the glove-puncturing object to hand 8 and into hand
wound 9. The liquid antiseptic composition can help to begin to
disinfect hand 8 and hand wound 9 immediately by inactivating,
killing and/or otherwise destroying any infectious pathogen
transferred to the hand and the hand wound.
In another embodiment of the present invention the glove can be
designed so that the liquid antiseptic composition in compartment 4
may be redistributed to better meet the needs of the glove wearer
following an accidental glove wall puncture. In other words, the
glove wearer can massage the glove wall to force the liquid
antiseptic composition in compartment 4 to accumulate near the
glove wall having the hole (the hole in glove wall puncture 10).
The thickness of compartment 4 in the glove wall is increased in
FIG. 2D compared to FIG. 2C to illustrate the point that an
accumulation of the liquid antiseptic composition may occur in
compartment 4 near glove wall puncture 10 as a result of glove
massage; the accumulation can cause the liquid antiseptic
composition in compartment 4 to leak at an increased rate onto the
hand and into the hand wound, and can provide additional liquid
antiseptic composition to treat hand 8 and hand wound 9 and as a
result can provide additional protection to hand 8 and to hand
wound 9. When the risk of infectious pathogen contamination to hand
8 and hand wound 9 is perceived by the gloved individual, even
reflex glove massage may be particularily effective method of using
the glove to quickly mobilize liquid antiseptic composition to
where it is best needed.
Should the leakage of liquid antiseptic composition from puncture
site 10 of outer glove layer 2 be deemed too excessive, the outward
leak can be attenuated or stopped as desired if the glove wearer
blocks puncture site 10 in outer glove layer 2 with a finger, a
piece of tape, or some another material such as a piece of paper
towel. Controlling outward leakage from the glove may help to
insure that a sufficient leakage of liquid antiseptic compositon
through puncture site 10 of inner glove layer 3 can occur onto hand
8 and into hand wound 9.
To make a glove in accordance with the present invention which has
an outer glove layer and an inner glove layer of similar elasticity
and similar plasticity, similar materials forming these glove
layers may be used and may comprise: (a) a structural material
selected from the group consisting of latex rubber,
cis-1,4-polyisoprene, cis-polybutadiene, neoprene rubber, nitrile
rubber, silicone rubber, another suitable rubber, cellulose acetate
plastic, vinyl plastic, polyethylene plastic, polypropylene
plastic, polyvinyl chloride plastic, polyvinyl acetate plastic,
polystyrene plastic, polymethyl methyl-acrylate plastic,
polyacrylonitrile plastic, vinyllite plastic, saran plastic,
polytetrafluoroethylene plastic, polytrifluorochloroethylene
plastic, polycaprolactam plastic, polyester plastic, urea
formaldehyde plastic, polyurethane plastic, isotactic polypropylene
plastic, nylon plastic, rayon plastic, polyamide plastic, phenolic
plastic, silicone plastic, another suitable plastic, silk fiber,
suitable fiber from an animal secretion, cotton fiber, cellulose
fiber, another suitable plant fiber, wool fiber, another suitable
animal fiber, animal hair, animal skin, animal intestinal tissue,
animal connective tissue, another suitable animal tissue, metal
fiber, mineral fiber, another suitable synthetic fiber, and
mixtures thereof; and (b) a colorant selected from the group
consisting of titanium oxide, an iron oxide, a dye and mixtures
thereof. In general, materials that form liquid permeable layers
may be coated or embedded with a liquid-impermeable material to
render the glove layer liquid-impermeable.
Alternatively, to make a glove in accordance with the present
invention having an inner glove layer of lower elasticity and
higher plasticity than the outer glove layer, the first material
(which is used for the outer glove layer) may comprise an elastic
structural material selected from the group consisting of latex
rubber, cis-1,4-polyisoprene rubber, cis-polybutadiene rubber,
neoprene rubber, nitrile rubber, silicone rubber, another suitable
rubber and mixtures thereof; and a colorant selected from the group
consisting of titanium oxide, an iron oxide, a dye and mixtures
thereof. The second material (used for the inner glove layer) may
comprise: a plastic structural material selected from the group
consisting of cellulose acetate plastic, vinyl plastic,
polyethylene plastic, polypropylene plastic, polyvinyl chloride
plastic, polyvinyl acetate plastic, polystyrene plastic, polymethyl
methylacrylate plastic, polyacrylonitrile plastic, vinyllite
plastic, saran plastic, polytetrafluoroethylene plastic,
polycaprolactam plastic, polytrifluorochloroethylene plastic, nylon
plastic, rayon plastic, polyester plastic, urea formaldehyde
plastic, polyurethane plastic, isotactic polypropylene plastic,
polyamide plastic, phenolic plastic, silicone plastic, another
suitable plastic, silk fiber, another suitable fiber from an animal
secretion, cotton fiber, another suitable plant fiber, wool fiber,
another suitable animal fiber, animal hair, animal skin, animal
intestinal and connective tissues, metallic fiber, mineral fiber,
chemically-modified natural fibers, chemical-modified synthetic
fibers another synthetic fiber, and mixtures thereof; and a
colorant selected from the group consisting of titanium oxide, an
iron oxide, a dye and mixtures thereof. Materials obtained from
animal intestinal tissues and animal connective tissue may comprise
the intestinal wall, ligaments, tendons and fascia and like tissue
obtained from slaughtered farm or ranch animals including the
following animals: cow, bull, sheep, steer, horse, chicken, goat,
mink, rabbit, and pig. Any animal may provide suitable raw
materials for the glove.
The colorants may be homogeneously mixed with the glove wall
structural materials to color the materials and/or to opacify the
materials. Alternatively one or more colorants or opacifiers and
mixtures thereof may be printed onto the glove wall or may color
the wall with a design or pattern that renders the glove wall
opaque or colored in a more pleasing decoration. The design or
pattern may have an appealing look or look funny so that the
patient of the glove wearer is less anxious and less frightened,
and is amused or calmed by the glove wearer; this effect is
particularily useful for calming children and other patients of a
gloved medical doctor or other health care worker. The design on
the gloves may in addition have a positive impact on the glove
wearer or provide written instructions or reminders to a gloved
worker of a procedure for example. Glove coloration or opacity can
also be used to help to make a glove in accordance with the present
invention have the appearance of a conventional medical glove. The
coloration or opacity of the glove wall can be used to obscure the
presence of the liquid antiseptic composition contained within the
thin glove wall of the present invvention.
A glove in accordance with the present invention will contain a
liquid antiseptic composition which comprises one or more
antiseptics in at least one liquid. As previously mentioned, a
liquid may function for some embodiments of the present invention
as both the antiseptic and the liquid in the liquid antiseptic
composition. An example is a liquid antiseptic composition that is
pure ethanol, pure isopropanol, or another liquid with an
antiseptic property. The antiseptic used in some embodiments of the
present invention may be selected from the group consisting of
chlorhexidine gluconate, chlorhexidine acetate, other chlorhexidine
salts, octoxynol, nonoxynol-9, methanol, ethanol, isopropanol,
allyl alcohol, sodium hypochlorite, potassium hypochlorite, sodium
dichloroisocyanurate, hypochlorous acid, acetic acid, sodium
acetate, trichloroacetic acid, benzoic acid, sodium benzoate, boric
acid, sodium borate, lactic acid, sodium lactate, chloramine,
elemental iodine, sodium iodide, potassium iodide, calcium iodide,
ammonium iodide, ferrous iodide, strontium iodide, lithium iodide,
magnesium iodide, zinc iodide, silver iodide, selenium iodide,
other iodide salts, povidone-iodine, iodinated organic compounds,
bromide salts, brominated organic compounds, suitable flouride
salts, formaldehyde, glutaraldehyde, mercurous chloride, zinc
nitrate, zinc sulfate, zinc oxide, zinc acetate, zinc chloride,
silver nitrate, silver sulfadiazine, hydrogen peroxide, benzoyl
peroxide, phenol, sodium phenolate, cresol, methylphenol,
resorcinol, orthophenylphenol, chloroxylenol, hexyl-resorcinol,
parachlorophenol, paratertiary-amylphenol, thymol, butylparaban,
ethylparaben, methylparaben, propylparaben, triclosan,
o-benzyl-p-chlorophenol, hexachlorophene, poloxamer 188,
benzalkonium chloride, benzethonium chloride, cetylpridinium
chloride, econazole, methylbenzethonium chloride,
cetyldimethylbenzylammonium chloride, triclocarban, clotrimazole,
ciclopirox olamine, undecylenic acid, miconazole, tolnaftate and
mixtures thereof.
The liquid antiseptic composition can be selected to be capable of
specifically killing, inactivating and/or otherwise destroying a
particular infectious pathogen. Alternatively, the liquid
antiseptic composition may be designed to have a broad spectrum
antiseptic activity against infectious pathogens. A glove in
accordance with the present invention may contain formulations of
the liquid antiseptic composition having potent antiseptic activity
against HIV or Hepatitis B virus.
Preferably the antiseptic used in the glove is selected from the
group consisting of povidone-iodine, elemental iodine, sodium
iodide, potassium iodide, sodium hypochlorite, nonoxynol-9, and
chlorhexidine gluconate and mixtures thereof because these
antiseptics can have effective viricidal or antiviral activity.
The inclusion of a metal ion chelator such as EDTA, EGTA, NTA,
HEDTA or other ion chelator at a concentration of between about 5
micromolar to about 5000 micromolar, in the liquid antiseptic
composition may be useful to help preserve the activity of the
antiseptic by chelating ions (cartons or anions) which may
chemically inactivate the antiseptic. Other preservatives which may
be added to the liquid antiseptic composition include pH buffers of
ascorbic acid and ascorbate salts, phosphate pH buffers, other pH
buffers, free radical scavengers, and reducing agents such as
dithiothreitol (DTT). Antiseptics whose activity may be stabilized
by a metal ion chelator or pH buffer include at least the following
antiseptics: hydrogen peroxide, benzoyl peroxide, other peroxide
antiseptics, sodium hypochlorite, potassium hypochlorite, sodium
dichloroisocyanurate, hypochlorous acid, iodine, sodium iodide,
potassium iodide and other halogen-releasing antiseptics.
The liquid antiseptic composition may contain a liquid selected
from the group consisting of water, methanol, ethanol, isopropanol,
propanol, allyl alcohol, butanol, isobutanol, sec-butanol,
tertbutanol, benzyl alcohol, 2-octyl dodecanol, other liquid
alcohols, glycerol, propylene glycol, a polyethylene glycol of
about 150 to about 600 molecular weight, other liquid polyethylene
glycols, other liquid glycols, urea, other liquid amides, acetone,
methyl ethyl ketone, ethyl ketone, methyl isopropyl ketone,
2-pentanone, ethyl acetate, ethyl propionate, ethyl butyrate, ethyl
valerate, methyl acetate, propyl acetate, butyl acetate, pentyl
acetate, isopentyl acetate, benzyl acetate, other liquid ketones,
other liquid esters, other liquid aldehydes, mineral oil, silicone
oil, other synthetic oils, hexamethyl disiloxane, other liquid
silanes, glycerol trioctanoate, decyl oleate, cetearyl
isononanoate, other liquid soaps, other liquid detergents,
dimethicone, other liquid silicones, perfluropolymethyisopropyl
ether of about 1500 to about 6600 molecular weight, other liquid
emulsifiers, olive oil, cottonseed oil, corn oil, soybean oil,
wheat germ oil, linseed oil, pine oil, almond oil, macadamia oil,
coconut oil, jojoba oil, peanut oil, persia oil, castor oil, other
vegetable oils, other plant oils, cod liver oil, shark liver oil,
mink oil, other animal oils, squalene, other liquid steroids, other
suitable naturally occurring liquids, other suitable man-made
liquids, and mixtures thereof.
Suitable materials, suitable liquids and other suitable chemicals
which may be used in the present invention are considered
"suitable" for the present invention when these substances (1)
function as required by the invention at the concentration used,
and (2) at that concentration cause only acceptably adverse
side-effects and toxicity to the human body. For example, some of
the more powerful liquid antiseptic compositions in the present
invention will protect a gloved individual from acquiring a
systemic HIV infection from an HIV and blood-tainted needlestick
injury to a hand, but in the process will probably at least
temporarily impair the healing process of the needlestick wound.
Such a negative effect of the present invention should be weighed
against the fact that the present invention can also prolong human
life and productivity.
It is generally useful to add to the liquid antiseptic composition,
at least one surface active agent to facilitate the coating of the
glove-puncturing object with the liquid antiseptic composition. The
surface active agent may be selected from the group consisting of
dodecyldimethylamine oxide, lauryldimethylamine oxide, stearic
acid, dibutyl adipate, octyl stearate, sodium cetearyl stearate,
isopropyl myristrate, palmitic acid, stearyl alcohol, colloidal
magnesium aluminum silicate, caprylic triglyceride, capric
triglyceride, decyl-beta-D-glucopyranoside, cetostearyl alcohol,
nonyl-beta-D-glucopyranoside, octyl-beta-D-glucopyranoside,
triethanolamine stearate, sodium lauryl sulfate,
heptyl-beta-D-glucopyranoside, hexyl-beta-D-glucopyranoside,
dodecyl-beta-D-maltoside, decyl-beta-D-maltoside, sodium
dodecylsulfate, sodium oleate, potassium laurate, sodium laurate,
sodium lauryl sulfate, glycerol monostearate, propylene glycol
monostearate, bis(2-ethylhexyl)sodium sulfosuccinate,
N-octylsulfobetaine, propylene glycol monolaurate,
N-dodecylsulfatobetaine, octyl-beta-D-thioglucopyranoside,
heptyl-beta-D-thioglucopyranoside, N-dodecyl-N,N-dimethyl-glycine,
cetyl alcohol, N-decylsulfatobetaine, digitonin,
N-hexyadecylsulfatobetaine, N-tetradecylsulfatobetaine, dioctyl
sodium sulfosuccinate, N,N,bis(3-D-gluconamidopropyl)cholamide,
sodium deoxycholate, N,N,bis(3-D-gluconamidopropyl)deoxycholamide,
glycerol monostearate, sodium taurodeoxycholate, sodium cholate,
sodium taurocholate, sodium glycocholate, cetyltrimethylammonium
bromide, 3-[(3-cholamidopropyl)dimethylammonio]-1-propanesulfonate,
3-[(3-cholamidopropyl)dimethylammonio]-2-hydroxypropane-1-sulfonate,
octanoyl-N-methylglucamide, nonanoyl-N-methylglucamide,
decanoyl-N-methylglucamide, nonyl-N-methylglucamide, lecithin,
lysolecithin, nonaethylene glycol monododecyl ether, nonaethylene
glycol octylphenol ether, nonaethylene glycol octylcyclohexyl
ether, heptaethylene glycol octylphenyl ether, heptaethylene glycol
octylcyclohexyl ether, polyoxyethylene (10) monolauryl ether,
polyoxyethylene (8) isotridecyl ether, polyoxyethylene (10)
isotridecyl ether, polyoxyethylene (15) isotridecyl ether,
polyoxyethylene (9) lauryl ether, polyoxyethylene (23) lauryl
ether, octaethylene glycol monododecyl ether, nonaethylene glycol
monododecyl ether, polyethylene polypropylene glycol, sorbitan
monopalmitate, sorbitan monooleate, sorbitan monostearate,
polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan
monooleate, polyoxyethylene-4-lauryl ether, polyethylene glycol 400
monostearate, polyoxyethylene-4-sorbitan monolaurate,
polyoxyethylene-20-sorbitan monooleate, polyoxyethylene-20-sorbitan
monopalmitate, polyoxyethylene-20-sorbitan monolaurate,
polyoxyethylene-40-stearate, dimethicone, simethicone,
dimethylpolysiloxane, sorbitan trioleate, sorbitan tristreate,
propylene glycol monostearate, sorbitan sesquioleate,
diphenylmethylsilicone, lauryldimethylbenzylammonium chloride, a
perfluropolymethylisopropyl ether of about 1500 to about 6600
molecular weight, acacia, type A gelatin, type B gelatin, egg yolk
phospholipids, soybean phospohlipids, cholesterol, colloidal
aluminum silicate, colloidal magnesium hydroxide, other suitable
surface active agents, and mixtures thereof.
The liquid antiseptic composition may contain an algesic agent to
increase the pain sensation perceived from a hand to alert the
individual when the hand has been wounded by a glove-puncturing
object. The algesic agent may be selected from the group consisting
of formic acid, acetic acid, citric acid, sodium hydrogen citrate,
other acidic citrate salts, other algesic organic acids, phosphoric
acid, sodium hydrogen phosphate, sodium phosphate, potassium
hydrogen phosphate, other acidic phosphate salts, other phosphate
salts, hydrochloric acid, sulfuric acid, sodium hydrogen sulfate,
sodium sulfate, other acidic sulfate salts, other algesic mineral
acids, sodium hypochlorite, potassium hypochlorite, other
hypochlorate salts, bradykinin, substance P, bee venom, wasp venom,
ant venom, other suitable algesic animal algesics, other algesic
peptides, algesic proteins, algesic ionophores, potassium chloride,
potassium citrate, potassium sulfate, potassium phosphate,
potassium carbonate, potassium bromide, potassium iodide, potassium
fluoride, potassium hydroxide, potassium nitrate, other potassium
salts, other potassium containing chemicals, other algesic organic
chemicals, other algesic salts, and mixtures thereof.
The liquid antiseptic composition may also contain a colorant as a
means for providing a colored visual signal to an individual when
the glove wall has been punctured by the glove-puncturing object;
the colorant is selected from the group consisting of the
forementioned dyes, iron oxides, titanium dioxide and mixtures
thereof. The colorant in the liquid antiseptiuc composition, glove
walls, or on the glove wall surfaces may be fluorescent,
phosphorescent, or glow in the dark after exposed to light as a
means of enhancing the coloration.
Coloration may also be employed using one or more of the
forementioned colorants to decorate the glove wall to give a glove
in accordance with the present invention a more pleasant
appearance. In some embodiments of the present invention, a colored
design or pattern is envisioned which comprises a pattern of small
animals including such as teddy bears, lions, giraffes, monkeys,
dogs, cats, mice, cows, chickens, pigs, sheep, elephants, birds and
the like animals. Other Figures decorating the glove may include
clowns, toys, fire trucks, cowboys, outdoor scenes and the like; in
general any scene or object which is pleasing to children and other
individuals is imagined to be a useful decoration for the present
invention. Glove coloration may be more abstract in pattern as
well, may include a camouflage pattern, or more simply color the
glove a single color such as pink, purple, white, green or any
other color including a fluorescent color. Preferably glove wall
coloration will render the glove wall opaque so that the liquid
antiseptic composition within the glove wall is masked from being
seen. In addition, printed diagrams, instructions, expressions, and
any other information may be printed onto the glove wall and may
accompany the coloration and glove wall decorations. Printing may
appear alone on the glove wall. An important object of the glove
wall coloration, decorations, and printing is to entertain and
lessen the fears of the glove wearer, and/or the patients of the
glove wearer. Such gloves should be particularily amusing to dental
patients and other health care patients. The method of achieving
the coloration, decoration and printing of the glove wall is not
conceived to be limited to any paticular artistic or commercial art
methodology.
The liquid antiseptic composition may further contain a
concentration of vasocontricting agent ranging from about 1 part
vasoconstricting agent in 200,000 parts of liquid antiseptic
composition to about 1 part vasoconstricting agent in 2,000 parts
of liquid antiseptic composition. Addition of a vasoconstricting
agent to the liquid antiseptic composition is useful as a means for
reducing blood flow in the hand wound to help to reduce the
spreading of the infectious pathogen from the wound should the
wound occur, into the systemic circulation (i.e., the blood
circulation, lymphatic circulation, interstitial serum circulation,
and other systemic fluid circulations) of an individual. The
vasoconstricting agent may be selected from the well known group of
vasocontricting ethylamine compounds or any other suitable group of
vasoconstricting compounds. Preferably the vasoconstricting agent
is selected from the group consisting of epinephrine,
norepinephrine, phenylephrine, ephedrine, metaraminol, methoxamine
and mixtures thereof.
The liquid antiseptic composition may further contain a
viscosity-modifying chemical such as a polymer or a highly-branched
molecule of high molecular weight, as a means for suitably
adjusting the viscosity of the liquid antiseptic composition. The
final viscosity of the liquid antiseptic composition may range from
less than one centipoise to more than 5000 centipoise at normal
glove temperatures which are generally expected to range between
about 10.degree. C. to about 45.degree. C. Thus, the liquid
antiseptic composition may have a low viscosity, similar to water,
or may have a higher viscosity, for example the viscosity of a
thick maple syrup or a bee honey. The viscosity-modifying polymer
may be selected from the group consisting of xantham gum, gum
acacia, gum tragacanth, agar, glycyrrhiza, sodium alginate, other
plant gums, cellulose, methyl cellulose, carboxymethylcellulose
sodium, other alkylated celluloses, other suitable
chemically-modified celluloses, glycerol, propylene glycol,
pyroxylin, polyethylene glycols of about 150 to about 600 molecular
weight, other polyethylene glycols, gelatin, other proteins,
dimethicone of about 100 to about 1000 centistokes viscosity,
simethicone, dimethylpolysiloxane, perfluropolymethylisopropyl
ether of about 1500 to about 6600 molecular weight, starch, other
alkylated starches, other chemically-modified starches, and
mixtures thereof. Certain polymers such as starch or povidone or
other molecules may complex iodine or other antiseptics and buffer
their free concentration in the liquid antiseptic composition. This
effect may need to be taken into account when formulating the
liquid antiseptic composition.
The liquid antiseptic composition may also contain a chemical odor
capable of causing either a pleasant or an unpleasant (malodorous)
smell. The chemical smell may be caused an aromatic oil, a perfume,
an ester, a ketone, an organic acid, a sulfide, an amine, a flower
extract, a plant extract, an animal extract, a mineral extract, or
another suitable chemical. When the glove is damaged, the chemical
odor may be released from the compartment storing the liquid
antiseptic composition; useful as a means for further alerting the
glove wearer or others that a protective glove has been
damaged.
Another embodiment of the present invention can be seen by
comparing the two partially enlarged sectional views of the glove
encircled in FIG. 3: a finger wall sectional view 11 and a wrist
wall sectional view 12. The thickness of compartment 4 storing
liquid antiseptic composition in wrist wall 12 is significantly
increased by design compared to the thickness of the compartment in
finger wall 12. The entire wrist area of the glove is expanded by
design so that the glove can store additional liquid antiseptic
composition in the wrist area.
By massaging the glove in any manner, the stored liquid antiseptic
composition can be redistributed by the glove wearer; useful as a
means for forcing the liquid antiseptic composition to flow to
other regions of the glove needing additional liquid antiseptic
composition such as the site of glove damage as depicted in FIG. 2D
where an accumulation of the liquid antiseptic composition can help
to increase the leak of liquid antiseptic composition from the
glove. A glove in accordance with the present invention may cover
the fingers, palm, back of hand, wrist, forearm or arm; any of
these regions of the glove can be modified by design so that a
portion of compartment 4 in the selected region may store
additional liquid antiseptic composition.
Once a particular formulation of liquid antiseptic composition has
been chosen, a glove in accordance with the present invention can
be made by many methods. One of the simplest ways to make a glove
in accordance with the present invention is first to form the inner
glove layer on a hand mold by one of the known methods used to form
standard medical gloves. Any other suitable method that could make
a glove layer is also acceptable. When the raw material to make the
glove layer is available in a liquid form, the hand mold may be
sprayed or dip coated with the liquid glove layer forming-material
and allowed to solidify. The outer glove layer can then be formed
on a second hand mold in the same manner. The outer glove layer can
have larger dimensions so that a suitably-sized compartment 4 for
the liquid antiseptic composition will be formed when the glove is
assembled. After the glove wall layer materials have set,
congealed, reacted, dried or solidified sufficiently, the outer
surface of the inner glove layer may be suitably coated with,
sprayed with, painted with or dip-coated with a selected amount of
a liquid antiseptic composition. The outer glove layer can then be
slipped over the liquid antiseptic coated inner glove layer. Extra
liquid antiseptic composition can be drained from or added to the
open end of compartment 4. The back ends of a glove in accordance
with the present invention may be sealed to completely close
compartment 4 or compartment 4 may be left open. A reversible seal
may be used at the open wrist end of the glove which comprises a
zip-locking connection between the glove layers or any other
suitable connecting device. Alternatively, a glove in accordance
with the present invention may have a simple structural design as
has been described in FIG. 1A wherein inner glove layer 3 and outer
glove layer 2 have no structural material connections. However, it
may be disadvantageous to leave compartment 4 unsealed because the
liquid antiseptic compostion may dry out or drain from the glove
during glove storage or glove wear. In addition, when the liquid
antiseptic composition is flammable, malodorous, or contains a
colorant, then sealing compartment 4 may be more appropriate.
Sealing of compartment 4 brings the inner and outer glove layers
into physical contact so they become structurally connected at
least at one point. A glue or any other means may be used to seal
compartment 4 at the open end of the glove. A glue can be used
which is capable of suitably bonding rubber, plastic and other
glove layer materials forming the glove wall and which is not
solubilized nor weakened by the liquid antiseptic composition. The
preferred sealing glue may contain a silicone, an epoxy polymer, an
epoxy resin, a cyanoacrylate, a cyanomethylacrylate, and the like,
or any other glue or bonding agent that remains suitable in the
presence of a particular liquid antiseptic composition.
Another alternative method of making a glove in accordance with the
present invention is to first form each glove layer on a hand mold,
and then slip (or slide) the outer glove layer over the inner glove
layer. Some liquid antiseptic composition can then be added to
suitably fill compartment 4 by using a tube, a funnel, by
injection, by simple pouring of the liquid into compartment 4 or by
any other method. The glove can then be sealed or left open at the
glove end.
Another alternative method for making the present invention is to
first add a liquid antiseptic composition to the inside of the
chosen outer glove layer. Then the inner glove layer can be
inserted within the outer glove layer. The glove can then be sealed
or left open at the glove end.
As mentioned, the liquid antiseptic composition may simply be pure
ethanol or another liquid having an antiseptic property. Thus, a
glove in accordance with the present invention can be made rather
easily by any individual using or wearing two gloves on each hand
containing a liquid antiseptic composition between the gloves on
each hand. The order of the steps by which the inner glove layer,
outer glove layer, and the liquid antiseptic composition are
combined to make the present invention is not in general
critical.
Another embodiment of the present invention is illustrated in FIG.
4 in the encircled partially enlarged sectional view; the glove
wall may have one structural connection, two structural
connections, or a plurality of structural connection 13 (of a third
material) in compartment 4 between the outer glove layer (first
material) and the inner glove layer (second material). The third
material forming a structural connection comprises:
(a) a structural material selected from the group consisting of
latex rubber, cis-1,4-polyisoprene rubber, cis-polybutadiene
rubber, neoprene rubber, nitrile rubber, silicone rubber, another
rubber, cellulose acetate plastic, vinyl plastic, polyethylene
plastic, polypropylene plastic, polyvinyl chloride plastic,
polyvinyl acetate plastic, polystyrene plastic, polymethyl
methylacrylate plastic, polyacrylonitrile plastic, vinyllite
plastic, saran plastic, polytetrafluoroethylene plastic,
polytrifluorochloroethylene plastic, nylon plastic, rayon plastic,
polycaprolactam plastic, polyester plastic, urea formaldehyde
plastic, polyurethane plastic, isotactic polypropylene plastic,
polyamide plastic, phenolic plastic, silicone plastic, another
plastic, another synthetic organic fiber, silk fiber, another
suitable fiber from an animal secretion, cotton fiber, another
plant fiber, wool fiber, another animal hair, leather, another
animal fiber, animal skin, animal intestinal tissue, animal
connective tissue, metallic fiber, mineral fiber, a glue comprising
one or more of the forementioned structural materials, and mixtures
thereof; and
(b) a colorant selected from the group consisting of titanium
dioxide, a dye, an iron oxide and mixtures thereof.
It is another object of the present invention to provide a glove
having a plurality of glove layers acting as a structural
connection which reconfigures the compartment storing the liquid
antiseptic composition into a plurality of compartments capable of
storing the liquid antiseptic composition.
It is another object of the present invention to provide a glove
having a plurality of glove layers acting as a structural
connection which reconfigures the compartment storing the liquid
antiseptic composition into a plurality of compartments storing the
components of the liquid antiseptic composition. For some
embodiments of the present invention, it is conceivable that the
chemical composition of the liquid antiseptic composition may be
more stable, potent or otherwise more suitable when some of the
components are kept physically separated from the rest until the
glove wall is punctured. The glove wall puncture in this case would
cause the components of the liquid antiseptic composition to mix
together or to chemically react at the site of the wall puncture to
form the liquid antiseptic composition to which the hand and hand
wound would then be exposed as a treatment of liquid antiseptic
composition.
It is another object of the present invention to provide a glove
having a plurality of glove layers acting as a structural
connection which reconfigures the compartment storing the liquid
antiseptic composition into a plurality of compartments which
macroscopically appear to the human eye (in a glove wall
cross-section) to comprise a sponge. The spongy glove wall has a
liquid impermeable coating or layer over at least the inner suface
and outer surface of the glove wall to prevent leakage of the
liquid antiseptic composition and to provide a suitable physical
barrier. The liquid impermeable coating or layer may comprise one
or more of the aformentioned structural glove wall materials. The
size of each compartment storing the liquid antiseptic composition
is not critical. Any of the compartments (for the present invention
compartments may also be called subcompartments) may be microscopic
in size, conceivably the pores in the spongy wall could be as small
as five microns (five millionths of an inch) or have dimensions
almost as large as the thickness of the glove wall.
It is another object of the present invention to provide a glove
having a plurality of structural connections that can be used to
strengthen the glove wall and/or which can be used to significantly
reconfigure compartment 4 storing the liquid antiseptic composition
into a plurality of subcompartments storing the liquid antiseptic
composition. Every subcompartment or only a portion of the
subcompartments may be connected to at least one adjacent
subcompartment. Such a glove can be massaged to optimally
redistribute the liquid antiseptic composition in the glove wall as
illustrated in FIG. 2D.
Alternatively each subcompartment may be a closed space, in which
case, glove massage would be marginally useful as a means for
redistributing the liquid antiseptic composition within the glove
wall. However, liquid antiseptic composition in the closed
subcompartments could conceivably be stored at a positive pressure
between normal atmospheric pressure and up to about three times
atmospheric pressure, so that liquid antiseptic composition would
be forcibly expelled from the pressurized subcompartments when an
object punctured one or more of them. Glove massage might also help
to expel the liquid antiseptic composition from this particular
glove wall design.
Another embodiment of the present invention is to have a glove
wherein only a portion of the subcompartments of the glove are
closed and wherein a portion of the subcompartments are open so
that the liquid antiseptic composition may flow from at least one
subcompartment to another subcompartment.
According to another embodiment of the present invention, the
compartment of the glove storing liquid antiseptic composition is
connected to one or more additional reservoir(s) of liquid
antiseptic composition by a one-way flow valve; a reservoir may be
incorporated by design anywhere on the glove. Preferably an
additional reservoir of liquid antiseptic composition would be
located on the proximal (wrist) end of the glove. In some
embodiments of the present invention, the additional reservoir
retains only about 0.1 milliliters of liquid antiseptic
composition. In other embodiments of the present invention, the
additional reservoir retains up to about 25 milliliters of liquid
antiseptic composition. The reservoir may be of a semi-spherical
(dome) shape or an annular or a semi-annular design and may provide
a manually-accessible reservoir of liquid antiseptic composition as
needed for hand and hand wound irrigation. In the event of a hand
wounding, the reservoir may be massaged, pushed, rolled forward,
forcefully smacked down on a firm surface, or pressurized by any
other means to release the liquid antiseptic composition from the
reservoir to the compartment of the glove and from there to the
hand wound site. Other conceivable means of resevoir massage are
also acceptable. Any conceivable reservoir design may be
acceptable, including a design incorporating a reinforced area
within the glove which is capable of withstanding the pressure
generated during reservoir massage. There may be a conduit with a
one-way or "flapper" valve between the reservoir and compartment 4
of the glove. The one-way valve or flapper valve can be used to
control the direction of liquid flow from the reservoir to the
compartment of the glove so that liquid antiseptic composition does
not flow back into the reservoir from the compartment of the glove;
the object of the additional reservoir(s) is to provide an
additional means for increasing the leakage of liquid antiseptic
composition from compartment 4 of the glove when the glove wall has
been punctured.
In another embodiment of the present invention a glove in
accordance with the present invention contains a liquid antiseptic
composition which comprises:
(a) about 0.02 to about 20 parts of povidone-iodine;
(b) about 0.1 to about 90 parts of water;
(c) about 0.05 to about 30 parts of a polyoxyethylene glycol of
about 150 to about 600 molecular weight; and
(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
In another embodiment of the present invention a glove in
accordance with the present invention contains a liquid antiseptic
composition which comprises:
(a) about 0.1 to about 20 parts of elemental iodine;
(b) about 0.1 to about 20 parts of sodium iodide;
(c) about 0.1 to about 30 parts of water;
(d) about 0.05 to about 30 parts of a polyoxyethylene glycol of
about 150 to about 600 molecular weight; and
(e) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
In another embodiment of the present invention a glove in
accordance with the present invention contains a liquid antiseptic
composition which comprises:
(a) about 0.1 to about 35 parts of sodium hypochlorite;
(b) about 50 to 99 parts of water;
(c) about 0.05 to about 30 parts of a polyoxyethylene glycol of
about 150 to about 600 molecular weight; and
(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
In another embodiment of the present invention a glove in
accordance with the present invention contains a liquid antiseptic
composition which comprises:
(a) about 0.1 to about 25 parts of chlorhexidine gluconate;
(b) about 0.1 to about 90 parts of water;
(c) about 0.05 to about 30 parts of a polyoxyethylene glycol of
about 150 to about 600 molecular weight; and
(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
In another embodiment of the present invention a glove in
accordance with the present invention contains a liquid antiseptic
composition which comprises:
(a) about 0.1 to about 50 parts of nonoxynol-9;
(b) about 0.1 to about 95 parts of water;
(c) about 0.05 to about 30 parts of a polyoxyethylene glycol of
about 150 to about 600 molecular weight; and
(d) about 0.1 to about 90 parts of an alcohol, the alcohol selected
from the group consisting of ethanol, isopropanol, propanol,
n-butanol, sec-butanol, tert-butanol, benzyl alcohol, methanol, and
mixtures thereof.
The preferred embodiment (See Example 4 below) of the present
invention is a flexible protective glove which comprises: an inner
layer 3 of polyethylene plastic which is about 1 mil in thickness:
an outer layer 2 of colored latex rubber which is between about 4
mils in thickness; and a compartment 4 containing approximately 10
milliliters of a liquid antiseptic composition comprising: between
about 2.5 parts of elemental iodine, about 2.5 parts of sodium
iodide, about 70 parts of ethanol, about 10 parts of distilled
water, 0.01 parts of FD&C red dye No.40 (#40) and about 5 parts
of polyoxyethylene glycol of about 400 grams per mole molecular
weight: wherein compartment 4 has a preferred thickness ranging
between about 1 mil to about 250 mils and is closed to prevent
evaporation. Note here that the term "parts" is a measure used in
the present invention meaning parts by weight and not parts by
volume.
The following Examples illustrate this invention.
EXAMPLE 1
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. (degrees Centigrade) by combining 10
grams of povidone-iodine, 10 grams of distilled water, 5 grams of
polyoxyethylene glycol 400 molecular weight, and 70 grams of
isopropanol and mixing for three hours in a glass 200 milliliter
flask. An inner glove layer of 5 mil thick latex rubber (first
material) is formed and cured until dry on a first hand mold. A
slightly larger outer glove layer of 5 mil thick white latex rubber
(first material) is formed and cured until dry on a second hand
mold, and then is evenly filled with the about 10 milliliters of
the liquid antiseptic composition. The outer glove layer is then
slipped over the inner glove layer on the first hand mold. The end
of compartment 4 of the glove is sealed using a silicone containing
glue.
EXAMPLE 2
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 10 grams of
povidone-iodine, 10 grams of distilled water, 5 grams of
polyoxyethylene glycol 400 molecular weight, and 70 grams of
denatured ethanol and mixing for three hours in a glass 200
milliter flask. An inner glove layer of 5 mil thick polyethylene
plastic (second material) is formed and cured until dry on a first
hand mold. A slightly larger outer glove layer of 5 mil thick white
latex rubber (first material) is formed and cured until dry on a
second hand mold, and then is evenly filled with the about 10
milliliters of the liquid antiseptic composition. The outer glove
layer is then slipped over the inner glove layer on the first hand
mold. The end of compartment 4 of the glove is sealed using a
silicone containing glue.
In a comparison test between glove materials made by the method of
Example 1 and glove materials made by the method of Example 2, more
liquid antiseptic composition was observed to leak from the inner
layer of a glove made by the method of Example 2, than a glove made
by the method of Example 1.
EXAMPLE 3
The gloves made for Example 3 are elongated in length compared to
the other Examples of the present invention from a length of 12
inches to a length of 30 inches) to include a protective arm
portion that could be extended to the shoulder and arm pit. About
285 milliliters of a liquid antiseptic composition is formulated at
23 C by combining 12 grams of elemental iodine, 1.5 grams of
distilled water, 15 grams of polyoxyethylene glycol 400 molecular
weight, and 270 grams of ethanol and mixing for three hours in a
glass 500 milliliter flask. An inner glove layer of 5 mil thick
polyethylene plastic (second material) is formed and cured until
dry on a long-armed first hand mold. A slightly larger outer glove
layer of 8 mil thick white latex rubber (first material) is formed
and cured until dry on a long-armed second hand mold, and then is
evenly filled with the about 100 milliliters of the liquid
antiseptic composition. The outer glove layer is then slipped over
the inner glove layer on the first hand mold. The end of
compartment 4 of the glove is sealed using a silicone containing
glue.
EXAMPLE 4
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 2.5 grams of elemental
iodine, 2.5 grams of sodium iodide, 10 grams of distilled water, 5
grams of polyoxyethylene glycol 400 molecular weight, 0.01 grams of
FD&C red dye No. 40, and 70 grams of ethanol and mixing for
three hours in a glass 200 milliliter flask. An inner glove layer
of 1 mil thick polyethylene plastic (second material) is formed and
cured until dry on a first hand mold. A slightly larger outer glove
layer of 4 mil thick white latex rubber (first material) is formed
and cured until dry on a second hand mold, and then is evenly
filled with the about 9 milliliters of the liquid antiseptic
composition. The outer glove layer is then slipped over the inner
glove layer on the first hand mold. The end of compartment 4 of the
glove is sealed using a silicone containing glue.
EXAMPLE 5
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 2.0 grams of elemental
iodine, 3.0 grams of sodium iodide, 50 grams of distilled water, 5
grams of polyoxyethylene glycol 400 molecular weight, 0.01 grams of
FD&C red dye No. 40, and 35 grams of ethanol and mixing for
three hours in a glass 200 milliliter flask. An inner glove layer
of 4 mil thick polyethylene plastic (second material) is formed and
cured until dry on a first hand mold. A slightly larger outer glove
layer of 4 mil thick white latex rubber (first material) is formed
and cured until dry on a second hand mold, and then is evenly
filled with the about 10 milliliters of the liquid antiseptic
composition. The outer glove layer is then slipped over the inner
glove layer on the first hand mold. The end of compartment 4 of the
glove is sealed using a silicone containing glue.
EXAMPLE 6
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 4.0 grams of sodium
hypochlorite, 70 grams of distilled water, 5 grams of
polyoxyethylene glycol 400 molecular weight, 0.01 grams of FD&C
red dye No. 40, 0.5 grams of titanium dioxide, and 25 grams of
ethanol and mixing for three hours in a glass 200 milliliter flask.
An inner glove layer of 4 mil thick polyethylene plastic (second
material) is formed and cured until dry on a first hand mold. A
slightly larger outer glove layer of 5 mil thick white latex rubber
(first material) is formed and cured until dry on a second hand
mold, and then is evenly filled with the about 10 milliliters of
the liquid antiseptic composition. The outer glove layer is then
slipped over the inner glove layer on the first hand mold. The end
of compartment 4 of the glove is sealed using a silicone containing
rubber glue.
EXAMPLE 7
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 4.0 grams of sodium
hypochlorite, 50 grams of distilled water, 5 grams of
polyoxyethylene glycol 400 molecular weight, 0.5 grams of red iron
oxide, 0.5 grams of titanium dioxide, and 45 grams of ethanol and
mixing for three hours in a glass 200 milliliter flask. An inner
glove layer of 3 mil thick polyethylene plastic (second material)
is formed and cured until dry on a first hand mold. A slightly
larger outer glove layer of 6 mil thick white latex rubber (first
material) is formed and cured until dry on a second hand mold, and
then is evenly filled with the about 10 milliliters of the liquid
antiseptic composition. The outer glove layer is then slipped over
the inner glove layer on the first hand mold. The end of
compartment 4 of the glove is sealed using a silicone containing
rubber glue.
EXAMPLE 8
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 5.0 grams of potassium
hypochlorite, 40 grams of distilled water, 5 grams of
polyoxyethylene glycol 400 molecular weight, 0.01 grams of FD&C
red dye No. 40, and 50 grams of ethanol and mixing for three hours
in a glass 200 milliliter flask. An inner glove layer of 6 mil
thick polyethylene plastic (second material) is formed and cured
until dry on a first hand mold. A slightly larger outer glove layer
of 6 mil thick white latex rubber (first material) is formed and
cured until dry on a second hand mold, and then is evenly filled
with the about 10 milliliters of the liquid antiseptic composition.
The outer glove layer is then slipped over the inner glove layer on
the first hand mold. The end of compartment 4 of the glove is
sealed using a silicone containing glue.
EXAMPLE 9
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 1.0 gram of sodium
hypochlorite, 20 grams of distilled water, 5 grams of
polyoxyethylene glycol 400 molecular weight, 0.01 grams of FD&C
red dye No. 40, and 20 grams of isopropanol, 20 grams of ethanol,
10 grams of benzyl alcohol, 10 grams of propanol, 10 grams of
tert-butanol and mixing for three hours in a glass 200 milliliter
flask. An inner glove layer of 6 mil thick polyethylene plastic
(second material) is formed and cured until dry on a first hand
mold. A slightly larger outer glove layer of 6 mil thick white
latex rubber (first material) is formed and cured until dry on a
second hand mold, and then is evenly filled with the about 10
milliliters of the liquid antiseptic composition. The outer glove
layer is then slipped over the inner glove layer on the first hand
mold. The end of compartment 4 of the glove is sealed using a
silicone containing glue.
EXAMPLE 10
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 4.0 grams of chlorhexidine
gluconate, 50 grams of distilled water, 5 grams of polyoxyethylene
glycol 400 molecular weight, 0.01 grams of FD&C red dye No. 40,
and 20 grams of isopropanol, 20 grams of ethanol, and mixing for
three hours in a glass 200 milliliter flask. An inner glove layer
of 6 mil thick polyethylene plastic (second material) is formed and
cured until dry on a first hand mold. A slightly larger outer glove
layer of 6 mil thick white latex rubber (first material) is formed
and cured until dry on a second hand mold, and then is evenly
filled with the about 10 milliliters of the liquid antiseptic
composition. The outer glove layer is then slipped over the inner
glove layer on the first hand mold. The end of compartment 4 of the
glove is sealed using a silicone containing glue.
EXAMPLE 11
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 4.0 grams of chlorhexidine
gluconate, 50 grams of distilled water, 5 grams of polyoxyethylene
glycol 400 molecular weight, 0.01 grams of FD&C red dye No. 40,
and 20 grams of isopropanol, 20 grams of ethanol, and mixing for
three hours in a glass 200 milliliter flask. An inner glove layer
of about 0.3 mil thick polyethylene plastic (second material) is
formed and cured until dry on a first hand mold. A slightly larger
outer glove layer of about 3 mil thick white latex rubber (first
material) is formed and cured until dry on a second hand mold, and
then is evenly filled with the about 10 milliliters of the liquid
antiseptic composition. The outer glove layer is then slipped over
the inner glove layer on the first hand mold. The end of
compartment 4 of the glove is sealed using a silicone containing
glue.
EXAMPLE 12
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 2.5 grams of chlorhexidine
gluconate, 50 grams of distilled water, 5 grams of polyoxyethylene
glycol 400 molecular weight, 0.01 grams of FD&C red dye No. 40,
and 40 grams of ethanol, and mixing for three hours in a glass 200
milliliter flask. An inner glove layer of 3 mil thick polyethylene
plastic (second material) is formed and cured until dry on a first
hand mold. A slightly larger outer glove layer of 3 mil thick white
latex rubber (first material) is formed and cured until dry on a
second hand mold, and then is evenly filled with the about 10
milliliters of the liquid antiseptic composition. The outer glove
layer is then slipped over the inner glove layer on the first hand
mold. The end of compartment 4 of the glove is sealed using a
silicone containing glue.
EXAMPLE 13
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 2.5 grams of chlorhexidine
gluconate, 50 grams of distilled water, 5 grams of polyoxyethylene
glycol 400 molecular weight, 0.01 grams of FD&C red dye No. 40,
and 40 grams of ethanol, and mixing for three hours in a glass 200
milliliter flask. An inner glove layer of 3 mil thick polyethylene
plastic (second material) is formed and cured until dry on a first
hand mold. A slightly larger outer glove layer of 3 mil thick white
latex rubber (first material) is formed and cured until dry on a
second hand mold, and then is evenly filled with the about 10
milliliters of the liquid antiseptic composition. The outer glove
layer is then slipped over the inner glove layer on the first hand
mold. The end of compartment 4 of the glove is sealed using a
silicone containing glue.
EXAMPLE 14
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 1.2 grams of chlorhexidine
gluconate, 15 grams of distilled water, 7 grams of polyoxyethylene
glycol 400 molecular weight, 0.01 grams of FD&C red dye No. 40,
and 75 grams of isopropanol, and mixing for three hours in a glass
200 milliliter flask. An inner glove layer of 5 mil thick
polyethylene plastic (second material) is formed and cured until
dry on a first hand mold. A slightly larger outer glove layer of 5
mil thick white latex rubber (first material) is formed and cured
until dry on a second hand mold, and then is evenly filled with the
about 10 milliliters of the liquid antiseptic composition. The
outer glove layer is then slipped over the inner glove layer on the
first hand mold. The end of compartment 4 of the glove is sealed
using a silicone containing glue.
EXAMPLE 15
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 8.5 grams of nonoxynol-9,
75 grams of distilled water, 4 grams of polyoxyethylene glycol 400
molecular weight, 0.01 grams of FD&C red dye No. 40, and 8
grams of isopropanol, and mixing for three hours in a glass 200
milliliter flask. An inner glove layer of 5 mil thick polyethylene
plastic (second material) is formed and cured until dry on a first
hand mold. A slightly larger outer glove layer of 5 mil thick white
latex rubber (first material) is formed and cured until dry on a
second hand mold, and then is evenly filled with the about 10
milliliters of the liquid antiseptic composition. The outer glove
layer is then slipped over the inner glove layer on the first hand
mold. The end of compartment 4 of the glove is sealed using a
silicone containing glue.
EXAMPLE 16
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 4.8 grams of nonoxynol-9,
35 grams of distilled water, 4 grams of polyoxyethylene glycol 400
molecular weight, 0.01 grams of FD&C red dye No. 40, and 45
grams of ethanol, and mixing for three hours in a glass 200
milliliter flask. An inner glove layer of 5 mil thick polyethylene
plastic (second material) is formed and cured until dry on a first
hand mold. A slightly larger outer glove layer of 6 mil thick white
latex rubber (first material) is formed and cured until dry on a
second hand mold, and then is evenly filled with the about 10
milliliters of the liquid antiseptic composition. The outer glove
layer is then slipped over the inner glove layer on the first hand
mold. The end of compartment 4 of the glove is sealed using a
silicone containing glue.
EXAMPLE 17
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 4.8 grams of nonoxynol-9,
35 grams of distilled water, 5 grams of polyoxyethylene glycol 400
molecular weight, 0.005 grams of bradykinin, 0.005 grams of
epinephrine, 0.01 grams of FD&C red dye No. 40, and 45 grams of
ethanol, and mixing for three hours in a glass 200 milliliter
flask. An inner glove layer of 5 mil thick polyethylene plastic
(second material) is formed and cured until dry on a first hand
mold. A slightly larger outer glove layer of 6 mil thick white
latex rubber (first material) is formed and cured until dry on a
second hand mold, and then is evenly filled with the about 10
milliliters of the liquid antiseptic composition. The outer glove
layer is then slipped over the inner glove layer on the first hand
mold. The end of compartment 4 of the glove is sealed using a
silicone containing glue.
EXAMPLE 18
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 2.4 grams of nonoxynol-9,
35 grams of distilled water, 5 grams of polyoxyethylene glycol 400
molecular weight, 0.005 grams of bradykinin, 0.01 grams of FD&C
red dye No. 40, and 45 grams of ethanol, and mixing for three hours
in a glass 200 milliliter flask. An inner glove layer of 5 mil
thick polyethylene plastic (second material) is formed and cured
until dry on a first hand mold. A slightly larger outer glove layer
of 6 mil thick white latex rubber (first material) is formed and
cured until dry on a second hand mold, and then is evenly filled
with the about 10 milliliters of the liquid antiseptic composition.
The outer glove layer is then slipped over the inner glove layer on
the first hand mold. The end of compartment 4 of the glove is
sealed using a silicone containing glue.
EXAMPLE 19
About 95 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 7.5 grams of potassium
iodide, 55 grams of distilled water, 5 grams of polyoxyethylene
glycol 400 molecular weight, 0.01 grams of FD&C red dye No. 40,
and 35 grams of ethanol, and mixing for three hours in a glass 200
milliliter flask. An inner glove layer of 6 mil thick polyethylene
plastic (second material) is formed and cured until dry on a first
hand mold. A slightly larger outer glove layer of 6 mil thick white
latex rubber (first material) is formed and cured until dry on a
second hand mold, and then is evenly filled with the about 10
milliliters of the liquid antiseptic composition. The outer glove
layer is then slipped over the inner glove layer on the first hand
mold. The end of compartment 4 of the glove is sealed using a
silicone containing glue.
EXAMPLE 20
About 85 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 2.5 grams of elemental
iodine, 3.5 grams of potassium iodide, 70 grams of ethanol, 10
grams of distilled water, 1 gram of polyoxyethylene glycol 400
molecular weight, and 0.01 grams of FD&C red dye No. 40, and
mixing for three hours in a glass 200 milliliter flask. An inner
glove layer of about 1 mil thick polyethylene plastic (second
material) is formed and cured until dry on a first hand mold. A
slightly larger outer glove layer of 4 mil thick white latex rubber
(first material) is formed and cured until dry on a second hand
mold, and then is evenly filled with the about 10 milliliters of
the liquid antiseptic composition. The outer glove layer is then
slipped over the inner glove layer on the first hand mold. The end
of compartment 4 of the glove is sealed using a silicone containing
glue.
EXAMPLE 21
About 85 milliliters of a liquid antiseptic composition is
formulated at 23.degree. C. by combining 2.5 grams of elemental
iodine, 3.5 grams of potassium iodide, 70 grams of ethanol, 10
grams of distilled water, 1 gram of polyoxyethylene glycol 400
molecular weight, and 0.01 grams of FD&C red dye No. 40, and
mixing for three hours in a glass 200 milliliter flask. An inner
glove layer of about 30 mils thick polyethylene plastic (second
material) is formed and cured until dry on a first hand mold. A
slightly larger outer glove layer of 40 mils thick white latex
rubber (first material) is formed and cured until dry on a second
hand mold, and then is evenly filled with the about 14 milliliters
of the liquid antiseptic composition. The outer glove layer is then
slipped over the inner glove layer on the first hand mold. The end
of compartment 4 of the glove is sealed using a silicone containing
glue. The thicker glove layers of this embodiment of the present
invention are designed to provide a strong physical barrier and
still provide a glove with suitable flexiblity for some gloved
workers.
While we have shown and described a number of embodiments of our
invention, it will be apparent to those skilled in the art that
many changes and modifications may be made without departing from
our present invention in its broader aspects. We therefore intend
the appended claims to cover all such changes and modifications as
fall within the true spirit and scope of our present invention.
* * * * *